Pulset
Pulset 3cc Syringe Blunt Tip Cannula (no Heparin), Pulset 1cc syringe blunt tip cannula 15u BH
1manufacturer
49catalogue numbers in this listing
14recalls on this code
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
Record
| Listed by | Westmed, Inc., United States |
|---|---|
| FDA product code | CBT |
| Device type | Arterial Blood Sampling Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 868.1100 |
| Establishment | Contract manufacturer, Remanufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-07-31 |
| Record revised | 2026-07-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| 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, manufacturing date |
| Packaging | Pack of 100, case of 100 |
| Distribution end date | 2026-05-05 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 3344-95 | In distribution | ||
| 3363-95S | In distribution | ||
| 3600-30 | 100 | In distribution | |
| 3342-95 | In distribution | ||
| 3353-95 | In distribution | ||
| 3300-95 | 100 | In distribution | |
| 3303-95S | 100 | In distribution | |
| 3372 | In distribution | ||
| 3703-91 | 100 | In distribution | |
| 3302-95S | 100 | Withdrawn | |
| 3183 | Withdrawn | ||
| 3702 | 100 | Withdrawn | |
| 3105 | 100 | Withdrawn | |
| 3163-95 | Withdrawn | ||
| 3700 | 100 | Withdrawn | |
| 3312-95 | 100 | Withdrawn | |
| 3173-95 | Withdrawn | ||
| 3103-91 | 100 | Withdrawn | |
| 3303-95 | 100 | Withdrawn | |
| 3363-91 | Withdrawn | ||
| 3302-91VT | 100 | Withdrawn | |
| 3373 | Withdrawn | ||
| 3313-91 | 100 | Withdrawn | |
| 3372-95 | Withdrawn | ||
| 3302-95 | 100 | Withdrawn | |
| 3300 | 100 | Withdrawn | |
| 3705 | 100 | Withdrawn | |
| 3373-91 | Withdrawn | ||
| 3303 | 100 | Withdrawn | |
| 3165-91 | Withdrawn | ||
| 3173-14 | Withdrawn | ||
| 3600-20 | 100 | Withdrawn | |
| 3103-95 | 100 | Withdrawn | |
| 3105-91 | 100 | Withdrawn | |
| 3105-95 | 100 | Withdrawn | |
| 3165-95 | Withdrawn | ||
| 3313-95 | 100 | Withdrawn | |
| 3302 | 100 | Withdrawn | |
| 3302-50 | 100 | Withdrawn | |
| 3393 | Withdrawn | ||
| 3600 | 100 | Withdrawn | |
| 3362-95 | Withdrawn | ||
| 3312-91 | 100 | Withdrawn | |
| 3193CH | Withdrawn | ||
| 3103 | 100 | Withdrawn | |
| 3322-95 | 100 | Withdrawn | |
| 3193 | Withdrawn | ||
| 3363-95 | Withdrawn | ||
| 3373-95 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 24 |
| Centurion | Centurion Medical Products Corporation | 22 |
| Medex | ICU Medical, Inc | 22 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 16 |
| AirLife™ | Airlife, Inc. | 16 |
| Deltran | Utah Medical Products, Inc. | 14 |
| A-Line | Westmed, Inc. | 12 |
| Pulset | SunMed Group Holdings, LLC | 11 |
| Atellica® VTR Syringes | SunMed Group Holdings, LLC | 7 |
| Blood Gas Sampler | Westmed, Inc. | 7 |
| Atellica® VTR Syringes | Westmed, Inc. | 5 |
| Arterial Blood Sampling Kit | Utah Medical Products, Inc. | 4 |
Showing 12 of 41. All products under Arterial Blood Sampling Kit
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| SunMed Group Holdings, LLC | UDI-DI | 2022-09-08 | Class II | Process control | The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle. | 53,560 units | 2024-06-18 |
Recalls
14 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 | Closed |
|---|---|---|---|---|---|
| 2011-01-18 | Class II | Material/Component Contamination | Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. | 1,259,200 units total | 2012-10-22 |
| 2011-01-18 | Class II | Material/Component Contamination | Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. | 1,259,200 units total | 2012-10-22 |
| 2011-01-18 | Class II | Material/Component Contamination | Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. | 1,259,200 units total | 2012-10-22 |
| 2011-01-18 | Class II | Material/Component Contamination | Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. | 1,259,200 units total | 2012-10-22 |
| 2011-01-18 | Class II | Material/Component Contamination | Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. | 1,259,200 units total | 2012-10-22 |
| 2011-01-18 | Class II | Material/Component Contamination | Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. | 1,259,200 units total | 2012-10-22 |
| 2011-01-18 | Class II | Material/Component Contamination | Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. | 1,259,200 units total | 2012-10-22 |
| 2011-01-18 | Class II | Material/Component Contamination | Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. | 1,259,200 units total | 2012-10-22 |
| 2011-01-18 | Class II | Material/Component Contamination | Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. | 1,259,200 units total | 2012-10-22 |
| 2011-01-18 | Class II | Material/Component Contamination | Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. | 1,259,200 units total | 2012-10-22 |
| 2011-01-18 | Class II | Material/Component Contamination | Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. | 1,259,200 units total | 2012-10-22 |
| 2011-01-18 | Class II | Material/Component Contamination | Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. | 1,259,200 units total | 2012-10-22 |
| 2011-01-18 | Class II | Material/Component Contamination | Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. | 1,259,200 units total | 2012-10-22 |
| 2011-01-18 | Class II | Material/Component Contamination | Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. | 1,259,200 units total | 2012-10-22 |
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.