Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)
FDA device recall Z-0731-2016 · posted 2016-01-30 · Terminated
Recall details
- Recalling firm
- Baxter Corporation Englewood
- Reason for recall
- All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product.
- Action taken
- An Urgent Product Recall notification was sent to consignees via USPS, first class mail on 12/21/15. Baxter Healthcare has asked customers to do the following: l. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product or shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return, credit and alternative products. 3. Complete the attached customer reply form and return it to Baxter by either fax or scanned e-mail. 4. Communicate the contents of the letter to your staff if affected products are distributed to other facilities or departments. 5. Conduct a consumer-level recall for dealers, wholesalers, distributors, resellers, or Original Equipment Manufacturers that distributed affected product to other facilities.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 4,695
- Distribution
- Worldwide Distribution-US (nationwide) and the countries of Canada, Sweden, Germany, and the Netherlands.
- Date initiated
- 2015-12-21
- Date posted
- 2016-01-30
- Date terminated
- 2016-08-18
- Location
- Englewood, CO
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TERUMO DISPOSABLE HYPODERMC SYRINGE (K980181) | Terumo Medical Corp. | 1998-04-02 |