PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with Microintroducer (with Lidocain) Th
FDA device recall Z-2049-2015 · posted 2015-07-08 · Terminated
Recall details
- Recalling firm
- Bard Access Systems
- Reason for recall
- Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.
- Action taken
- BARD sent an Urgent Notification letter dated May 27, 2015, to all affected consignees via FedEx. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed that they may choose to return the affected product to Bard Access Systems or use with the understanding that the correct expiration date is November 2015 (2015-11). Customers with questions were instructed to call 1-800-290-1689. For questions regarding this recall call 801-522-5974.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- LJS
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-05-27
- Date posted
- 2015-07-08
- Date terminated
- 2016-02-10
- Location
- Salt Lake City, UT
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET (K091324) | C.R. Bard, Inc. | 2009-08-07 |
| POWERPICC SOLO (K072230) | C.R. Bard, Inc. | 2007-10-05 |