Design Options®
Baystate Medical CTR - Original Customer
1manufacturer
361catalogue numbers in this listing
17recalls on this code
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
Record
| Listed by | B. Braun Medical Inc., United States |
|---|---|
| FDA product code | OGE |
| Device type | Epidural Anesthesia Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5120 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2024-07-29 (version 8) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 20 to 25 °C; Handling environment temperature 1 to 40 °C |
| Distribution end date | 2026-06-16 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 555498 | Gauge epidural needle : 17 | 10 | In distribution |
| 551942 | Gauge epidural needle : 17 | 10 | In distribution |
| 551960 | Gauge epidural needle : 20 | 10 | In distribution |
| 555212 | 10 | In distribution | |
| 552195 | Gauge epidural needle : 17 | 10 | In distribution |
| 552150 | Gauge (Catheter) : 19 | 10 | In distribution |
| 552030 | Gauge (Catheter) : 20 | 10 | In distribution |
| 552131 | Gauge epidural needle : 17 | 10 | In distribution |
| 552148 | Gauge epidural needle : 18 | 10 | In distribution |
| 551630 | Gauge (Catheter) : 19 | 10 | In distribution |
| 555525 | Gauge epidural needle : 17 | 10 | In distribution |
| 551028 | Gauge epidural needle : 17 | 10 | In distribution |
| 555357 | Gauge epidural needle : 17 | 10 | In distribution |
| 555422 | Gauge epidural needle : 17 | 10 | In distribution |
| 555779 | Gauge (Catheter) : 20 | 10 | In distribution |
| 551859 | Gauge epidural needle : 18 | 10 | In distribution |
| 555259 | Gauge (Catheter) : 20 | 10 | In distribution |
| 555202 | Gauge (Catheter) : 20 | 10 | In distribution |
| 552158 | 10 | In distribution | |
| 555602 | Gauge epidural needle : 18 | 10 | In distribution |
| 551675 | Gauge epidural needle : 18 | 10 | In distribution |
| 551266 | Gauge epidural needle : 18 | 10 | In distribution |
| 552055 | Gauge epidural needle : 18 | 10 | In distribution |
| 552132 | Gauge (Catheter) : 19 | 10 | In distribution |
| 555940 | Gauge epidural needle : 18 | 10 | In distribution |
| 551367 | Gauge epidural needle : 20 | 10 | In distribution |
| 551920 | Gauge (Catheter) : 20 | 10 | In distribution |
| 552142 | Gauge epidural needle : 18 | 10 | In distribution |
| 551342 | Gauge epidural needle : 18 | 10 | In distribution |
| 552144 | 10 | In distribution | |
| 552162 | Gauge epidural needle : 20 | 10 | In distribution |
| 551918 | Gauge epidural needle : 18 | 10 | In distribution |
| 552150 | Gauge epidural needle : 17 | 10 | In distribution |
| 555569 | Gauge epidural needle : 17 | 10 | In distribution |
| 552176 | Gauge epidural needle : 17 | 10 | In distribution |
| 551995 | 10 | In distribution | |
| 551948 | Gauge epidural needle : 20 | 10 | In distribution |
| 552041 | Gauge (Catheter) : 20 | 10 | In distribution |
| 552191 | Gauge epidural needle : 18 | 10 | In distribution |
| 555669 | Gauge epidural needle : 18 | 10 | In distribution |
| 551022 | Gauge epidural needle : 20 | 10 | In distribution |
| 551554 | Gauge (Catheter) : 19 | 10 | In distribution |
| 552116 | Gauge (Catheter) : 19 | 10 | In distribution |
| 551714 | Gauge epidural needle : 17 | 10 | In distribution |
| 552160 | Gauge spinal needle : 20 | 10 | In distribution |
| 551970 | Gauge epidural needle : 20 | 10 | In distribution |
| 552180 | Gauge epidural needle : 17 | 10 | In distribution |
| 552136 | Gauge spinal needle : 17 | 10 | In distribution |
| 555987 | Gauge epidural needle : 17 | 10 | In distribution |
| 552163 | Gauge epidural needle : 18 | 10 | In distribution |
| 552065 | Gauge epidural needle : 18 | 10 | In distribution |
| 551519 | Gauge epidural needle : 20 | 10 | In distribution |
| 552125 | Gauge epidural needle : 17 | 10 | In distribution |
| 552178 | Gauge (Catheter) : 19 | 10 | In distribution |
| 552179 | Gauge epidural needle : 17 | 10 | In distribution |
| 555706 | Gauge epidural needle : 18 | 10 | In distribution |
| 551064 | Gauge epidural needle : 18 | 10 | In distribution |
| 555757 | Gauge epidural needle : 18 | 10 | In distribution |
| 551959 | Gauge epidural needle : 18 | 10 | In distribution |
| 555382 | Gauge epidural needle : 18 | 10 | In distribution |
| 552192 | Gauge (Catheter) : 19 | 10 | In distribution |
| 551797 | Gauge epidural needle : 18 | 10 | In distribution |
| 552190 | Gauge epidural needle : 18 | 10 | In distribution |
| 552099 | 10 | In distribution | |
| 555421 | Gauge (Catheter) : 20 | 10 | In distribution |
| 552197 | Gauge epidural needle : 17 | 10 | In distribution |
| 551951 | Gauge (Catheter) : 20 | 10 | In distribution |
| 552071 | 10 | In distribution | |
| 555484 | Gauge epidural needle : 17 | 10 | In distribution |
| 551703 | Gauge epidural needle : 20 | 10 | In distribution |
| 555647 | Gauge epidural needle : 18 | 10 | In distribution |
| 551982 | Gauge epidural needle : 18 | 10 | In distribution |
| 555780 | Gauge epidural needle : 20 | 10 | In distribution |
| 552152 | Gauge epidural needle : 17 | 10 | In distribution |
| 552177 | Gauge spinal needle : 17 | 10 | In distribution |
| 552153 | Gauge epidural needle : 17 | 10 | In distribution |
| 555098 | Gauge (Catheter) : 19 | 10 | In distribution |
| 552011 | Gauge (Catheter) : 19 | 10 | In distribution |
| 552021 | Gauge (Catheter) : 20 | 10 | In distribution |
| 552183 | Gauge epidural needle : 18 | 10 | In distribution |
| 555194 | Gauge epidural needle : 18 | 10 | In distribution |
| 552209 | Gauge (Catheter) : 19 | 10 | In distribution |
| 551115 | Gauge epidural needle : 20 | 10 | In distribution |
| 551749 | Gauge (Catheter) : 19 | 10 | In distribution |
| 552154 | Gauge (Catheter) : 19 | 10 | In distribution |
| 552175 | Gauge (Catheter) : 19 | 10 | In distribution |
| 555325 | Gauge (Catheter) : 20 | 10 | In distribution |
| 552181 | Gauge (Catheter) : 19 | 10 | In distribution |
| 552123 | Gauge (Catheter) : 19 | 10 | In distribution |
| 555204 | Gauge epidural needle : 17 | 10 | In distribution |
| 552166 | Gauge epidural needle : 20 | 10 | In distribution |
| 552146 | Gauge epidural needle : 18 | 10 | In distribution |
| 555040 | Gauge epidural needle : 18 | 10 | In distribution |
| 551994 | Gauge epidural needle : 18 | 10 | In distribution |
| 551816 | Gauge epidural needle : 18 | 10 | In distribution |
| 555215 | Gauge (Catheter) : 20 | 10 | In distribution |
| 551665 | 10 | In distribution | |
| 552188 | 10 | In distribution | |
| 552076 | Gauge epidural needle : 17 | 10 | In distribution |
| 555217 | Gauge epidural needle : 18 | 10 | In distribution |
| 552189 | Gauge epidural needle : 17 | 10 | In distribution |
| 552207 | Gauge epidural needle : 17 | 10 | In distribution |
| 552048 | Gauge epidural needle : 17 | 10 | In distribution |
| 555156 | Gauge epidural needle : 18 | 10 | In distribution |
| 551987 | Gauge epidural needle : 20 | 10 | In distribution |
| 551845 | Gauge epidural needle : 20 | 10 | In distribution |
| 552173 | Gauge (Catheter) : 19 | 10 | In distribution |
| 555854 | Gauge (Catheter) : 20 | 10 | In distribution |
| 555450 | Gauge (Catheter) : 19 | 10 | In distribution |
| 555601 | Gauge epidural needle : 18 | 10 | In distribution |
| 551416 | Gauge epidural needle : 20 | 10 | In distribution |
| 551853 | 10 | In distribution | |
| 555296 | Gauge epidural needle : 17 | 10 | In distribution |
| 552051 | Gauge epidural needle : 17 | 10 | In distribution |
| 551148 | Gauge epidural needle : 20 | 10 | In distribution |
| 552149 | Gauge epidural needle : 17 | 10 | In distribution |
| 552208 | Gauge epidural needle : 19 | 10 | In distribution |
| 551769 | Gauge (Catheter) : 19 | 10 | In distribution |
| 551474 | Gauge (Catheter) : 19 | 10 | In distribution |
| 551944 | Gauge epidural needle : 20 | 10 | In distribution |
| 552106 | Gauge epidural needle : 22 | 10 | In distribution |
| 552113 | Gauge (Catheter) : 19 | 10 | In distribution |
| 552103 | Gauge epidural needle : 17 | 10 | In distribution |
| 555070 | Gauge epidural needle : 18 | 10 | In distribution |
| 551731 | Gauge epidural needle : 18 | 10 | In distribution |
| 551956 | Gauge epidural needle : 17 | 10 | In distribution |
| 555083 | Gauge (Catheter) : 20 | 10 | In distribution |
| 555803 | Gauge epidural needle : 17 | 10 | In distribution |
| 552187 | 10 | In distribution | |
| 552133 | Gauge (Catheter) : 19 | 10 | In distribution |
| 552182 | Gauge epidural needle : 20 | 10 | In distribution |
| 555271 | Gauge (Catheter) : 20 | 10 | In distribution |
| 551310 | Gauge epidural needle : 20 | 10 | In distribution |
| 555551 | Gauge (Catheter) : 20 | 10 | In distribution |
| 552137 | Gauge epidural needle : 20 | 10 | In distribution |
| 552194 | Gauge (Catheter) : 19 | 10 | In distribution |
| 552077 | Gauge epidural needle : 17 | 10 | In distribution |
| 555483 | Gauge (Catheter) : 20 | 10 | In distribution |
| 552159 | Gauge spinal needle : 18 | 10 | In distribution |
| 555340 | Gauge epidural needle : 18 | 10 | In distribution |
| 551563 | Gauge epidural needle : 17 | 10 | In distribution |
| 552057 | Gauge epidural needle : 17 | 10 | In distribution |
| 552186 | 10 | In distribution | |
| 551366 | Gauge epidural needle : 18 | 10 | In distribution |
| 552036 | Gauge epidural needle : 20 | 10 | In distribution |
| 552147 | Gauge epidural needle : 17 | 10 | In distribution |
| 551791 | Gauge (Catheter) : 20 | 10 | In distribution |
| 555110 | Gauge epidural needle : 17 | 10 | In distribution |
| 555030 | Gauge epidural needle : 18 | 10 | In distribution |
| 555660 | Gauge (Catheter) : 20 | 10 | In distribution |
| 552018 | 10 | In distribution | |
| 555063 | Gauge (Catheter) : 20 | 10 | In distribution |
| 552171 | 10 | In distribution | |
| 552165 | Gauge epidural needle : 18 | 10 | In distribution |
| 551997 | Gauge (Catheter) : 19 | 10 | In distribution |
| 555067 | Gauge (Catheter) : 20 | 10 | In distribution |
| 552038 | Gauge epidural needle : 17 | 10 | In distribution |
| 555076 | 10 | In distribution | |
| 552119 | Gauge epidural needle : 17 | 10 | In distribution |
| 555525 | Gauge (Catheter) : 19 | 10 | In distribution |
| 555449 | Gauge epidural needle : 18 | 10 | In distribution |
| 551875 | Gauge epidural needle : 17 | 10 | In distribution |
| 551732 | Gauge epidural needle : 17 | 10 | In distribution |
| 552117 | Gauge epidural needle : 17 | 10 | In distribution |
| 552141 | Gauge epidural needle : 18 | 10 | In distribution |
| 551889 | Gauge (Catheter) : 19 | 10 | In distribution |
| 551879 | Gauge (Catheter) : 20 | 10 | In distribution |
| 551829 | Gauge epidural needle : 18 | 10 | In distribution |
| 552126 | Gauge (Catheter) : 19 | 10 | In distribution |
| 551971 | Gauge (Catheter) : 19 | 10 | In distribution |
| 552193 | Gauge (Catheter) : 19 | 10 | In distribution |
| 555091 | Gauge (Catheter) : 20 | 10 | In distribution |
| 551922 | Gauge (Catheter) : 20 | 10 | In distribution |
| 551958 | Gauge epidural needle : 17 | 10 | In distribution |
| 552006 | Gauge (Catheter) : 19 | 10 | In distribution |
| 552174 | Gauge spinal needle : 17 | 10 | In distribution |
| 551672 | Gauge (Catheter) : 20 | 10 | In distribution |
| 552062 | 10 | In distribution | |
| 552203 | Gauge (cannula) : 20 | 10 | In distribution |
| 552135 | Gauge (Catheter) : 19 | 10 | In distribution |
| 552031 | Gauge (Catheter) : 20 | 10 | In distribution |
| 555946 | Gauge epidural needle : 20 | 10 | In distribution |
| 552020 | Gauge (Catheter) : 19 | 10 | In distribution |
| 555100 | Gauge (Catheter) : 20 | 10 | In distribution |
| 551965 | Gauge epidural needle : 22 | 10 | In distribution |
| 552120 | Gauge (Catheter) : 19 | 10 | In distribution |
| 555876 | Gauge epidural needle : 18 | 10 | In distribution |
| 555438 | Gauge (Catheter) : 20 | 10 | In distribution |
| 551677 | Gauge epidural needle : 18 | 10 | In distribution |
| 551531 | Gauge epidural needle : 20 | 10 | In distribution |
| 552155 | Gauge epidural needle : 17 | 10 | In distribution |
| 552105 | 10 | In distribution | |
| 551676 | 10 | In distribution | |
| 552185 | 10 | In distribution | |
| 552110 | Gauge epidural needle : 20 | 10 | In distribution |
| 551773 | Gauge (Catheter) : 19 | 10 | In distribution |
| 555077 | Gauge epidural needle : 18 | 10 | In distribution |
| 551572 | Gauge (Catheter) : 20 | 10 | In distribution |
| 551771 | Gauge epidural needle : 18 | 10 | In distribution |
| 555884 | Gauge epidural needle : 17 | 10 | In distribution |
| 552161 | Gauge spinal needle : 18 | 10 | In distribution |
| 551273 | Gauge epidural needle : 20 | 10 | In distribution |
| 551998 | Gauge (Catheter) : 19 | 10 | In distribution |
| 555904 | Gauge (Catheter) : 20 | 10 | In distribution |
| 552101 | Gauge epidural needle : 17 | 10 | In distribution |
| 552034 | Gauge epidural needle : 18 | 10 | In distribution |
| 552138 | Gauge (Catheter) : 17 | 10 | Withdrawn |
| 551250 | Gauge epidural needle : 20 | 10 | Withdrawn |
| 551937 | Gauge epidural needle : 18 | 10 | Withdrawn |
| 555328 | Gauge epidural needle : 17 | 10 | Withdrawn |
| 555007 | Gauge epidural needle : 18 | 10 | Withdrawn |
| 555079 | Gauge (Catheter) : 19 | 10 | Withdrawn |
| 552079 | Gauge epidural needle : 17 | 10 | Withdrawn |
| 555277 | Gauge (Catheter) : 20 | 10 | Withdrawn |
| 552164 | Gauge epidural needle : 20 | 10 | Withdrawn |
| 552063 | Gauge epidural needle : 20 | 10 | Withdrawn |
| 551941 | Gauge (Catheter) : 20 | 10 | Withdrawn |
| 552114 | Gauge (Catheter) : 19 | 10 | Withdrawn |
| 552088 | Gauge (Catheter) : 19 | 10 | Withdrawn |
| 551823 | Gauge (Catheter) : 19 | 10 | Withdrawn |
| 555018 | Gauge epidural needle : 18 | 10 | Withdrawn |
| 551979 | Gauge epidural needle : 18 | 10 | Withdrawn |
| 555374 | Gauge (Catheter) : 20 | 10 | Withdrawn |
| 551930 | Gauge epidural needle : 20 | 10 | Withdrawn |
| 555428 | Gauge (Catheter) : 20 | 10 | Withdrawn |
| 551264 | Gauge epidural needle : 20 | 10 | Withdrawn |
| 552128 | Gauge epidural needle : 20 | 10 | Withdrawn |
| 552112 | Gauge (Catheter) : 19 | 10 | Withdrawn |
| 555872 | Gauge epidural needle : 20 | 10 | Withdrawn |
| 551992 | 10 | Withdrawn | |
| 552069 | Gauge epidural needle : 18 | 10 | Withdrawn |
| 552109 | 10 | Withdrawn | |
| 551010 | Gauge epidural needle : 18 | 10 | Withdrawn |
| 552115 | Gauge (Catheter) : 19 | 10 | Withdrawn |
| 555134 | Gauge (Catheter) : 20 | 10 | Withdrawn |
| 551006 | Gauge epidural needle : 20 | 10 | Withdrawn |
| 551411 | Gauge (Catheter) : 20 | 10 | Withdrawn |
| 555051 | Gauge epidural needle : 17 | 10 | Withdrawn |
| 552124 | Gauge (Catheter) : 19 | 10 | Withdrawn |
| 551736 | Gauge epidural needle : 17 | 10 | Withdrawn |
| 555392 | Gauge (Catheter) : 19 | 10 | Withdrawn |
| 555144 | Gauge (Catheter) : 20 | 10 | Withdrawn |
| 552087 | Gauge (Catheter) : 19 | 10 | Withdrawn |
| 551993 | Gauge (Catheter) : 19 | 10 | Withdrawn |
| 555016 | Gauge epidural needle : 18 | 10 | Withdrawn |
| 555338 | Gauge epidural needle : 18 | 10 | Withdrawn |
| 555182 | Gauge (Catheter) : 19 | 10 | Withdrawn |
| 551983 | Gauge epidural needle : 18 | 10 | Withdrawn |
| 555151 | Gauge (Catheter) : 20 | 10 | Withdrawn |
| 555556 | Gauge epidural needle : 18 | 10 | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 1,319 |
| Medline Industries, Inc. | Medline Industries, Inc. | 504 |
| Perifix® | B. Braun Medical Inc. | 118 |
| Aligned Medical Solutions | Aligned Medical Solutions | 77 |
| Arrow | Teleflex Medical LLC | 15 |
| Epidural Anesthesia Kit Clint Pharmaceuticals | CHS USA Incorporated | 11 |
| Epidural Anesthesia Kit | Pajunk Medical Systems, LP | 11 |
| Epidural Anesthesia Kit | Custom Interventional Pain Management | 10 |
| ACS | American Contract Systems, Inc. | 8 |
| Stradis Healthcare | Stradis Healthcare | 5 |
| Medline | Medline Industries, Inc. | 4 |
| Epidural Anesthesia Kit | CHS USA Incorporated | 4 |
Showing 12 of 18. All products under Epidural Anesthesia Kit
Recalls Naming This Product
6 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| B. Braun Medical Inc. | UDI-DI | 2026-01-29 | Class II | Process control | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the p | 280 |
| B. Braun Medical Inc. | UDI-DI | 2026-01-29 | Class II | Process control | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the p | 690 |
| B. Braun Medical Inc. | UDI-DI | 2026-01-29 | Class II | Process control | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the p | 690 |
| B. Braun Medical Inc. | UDI-DI | 2026-01-29 | Class II | Process control | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the p | 680 |
| B. Braun Medical Inc. | UDI-DI | 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 5,770 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2023-06-05 | Class II | Mixed-up of materials/components | Kits were assembled with the incorrect Filter Straw. | 3,560 units |
Recalls
12 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 2,450 units |
| 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 10,130 units |
| 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 0 units |
| 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 48,110 units |
| 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 2,760 units |
| 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 0 units |
| 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 0 units |
| 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 2,840 units |
| 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 0 units |
| 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 60 units |
| 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 0 units |
| 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 21,270 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.