500ml Ultimate Lockbox
Lockbox compatible with bags up to 500 mL, syringes 20 mL to 60 mL, and bottles up to 50 mm in diameter (1), keys (2), Instructions for Use (1).
5manufacturers in China registered for this device type
1catalogue number
10recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Zyno Electric & Machinery Ltd, Shanghai | Shanghai | Shanghai | Contract manufacturer | 1 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Record
| Listed by | CME America, LLC |
|---|---|
| FDA product code | FRN |
| Device type | Pump, Infusion |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Record published | 2017-01-11 |
| Record revised | 2022-07-04 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2020-10-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 190-900PXCVP | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Port Access Infusion SET | Sb-Kawasumi Laboratories, Inc. | 76 |
| Cadd | ICU Medical, Inc | 56 |
| Flow Control Tubing | GO Medical Industries PTY. Ltd. | 39 |
| Curlin Administration Set | Zevex, Inc. | 30 |
| ambIT | Summit Medical Products, Inc. | 27 |
| Beeline motIV | Rex Pj Tech LLC | 24 |
| RMS Precision Flow Rate TubingTM | Repro-Med Systems, Inc. | 24 |
| Medfusion | ICU Medical, Inc | 24 |
| Volumat™ Line | Fresenius Kabi AB | 24 |
| Outlook® | B. Braun Medical Inc. | 21 |
| Alaris | CareFusion 303, Inc | 19 |
| Alpha Source Battery | Alpha Source Inc. | 17 |
Showing 12 of 191. All products under Pump, Infusion
Recalls
2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 | Closed |
|---|---|---|---|---|---|
| 2020-07-30 | Class II | Other | Multiple reasons: 1) Due to wear and tear of pump motor block mechanism – may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process. | Total pumps = 4,182 (all models) | 2022-03-08 |
| 2020-07-30 | Class II | Other | Multiple reasons: 1) Due to wear and tear of pump motor block mechanism – may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process. | Total pumps = 4,182 (all models) | 2022-03-08 |
| 2020-07-30 | Class II | Other | Multiple reasons: 1) Due to wear and tear of pump motor block mechanism – may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process. | Total pumps = 4,182 (all models) | 2022-03-08 |
| 2020-07-30 | Class II | Other | Multiple reasons: 1) Due to wear and tear of pump motor block mechanism – may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process. | Total pumps = 4,182 (all models) | 2022-03-08 |
| 2020-07-30 | Class II | Other | Multiple reasons: 1) Due to wear and tear of pump motor block mechanism – may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process. | Total Pumps = 4,182 (all models) | 2022-03-08 |
| 2020-07-30 | Class II | Other | Multiple reasons: 1) Due to wear and tear of pump motor block mechanism – may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process. | Total pumps = 4,182 (all models) | 2022-03-08 |
| 2020-02-27 | Class II | Employee error | The wall charger may not properly charge the infusion pump battery. | 27 chargers | 2022-01-26 |
| 2020-01-07 | Class I | Device Design | Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster than expected drug delivery when infusing at a very low rate (0.1 mL/h), or 2) slower than expected drug delivery when infusing at high flow ra | 30,596 pumps | 2022-04-14 |
| 2019-09-16 | Class I | Nonconforming Material/Component | When using a specific tubing set with infusion pump system, may result in under deliver of fluids. | 69400 infusion sets | 2022-04-13 |
| 2015-01-16 | Class II | Software design | CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery. | 3,186 | 2017-03-31 |
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.