Recall Z-1338-2018 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
Ethicon, Inc.
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
| Date | Jan 10, 2018 |
| Status | Terminated |
| Reason | Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture. |
| Root cause | Process control |
| Action | On January 10, 2018 an URGENT MEDICAL DEVICE LETTER for removal was issued to customers requesting that all affected personnel to discontinue use or distribution of the recalled product. The following actions being required: 1. Examine inventory and quarantine all affected product 2. Communicate this recall notice to all affected personnel at facility, or other affected facilities. 3. Complete the business reply form attached to the recall letter. 4. Keep the recall notice posted visibly at facility and maintain a copy with your records 5. Return unused product to recalling firm by April 13, 2 |
| Quantity | 7020 |
| Distribution | Distribution US Nationwide, Canada, India, and Colombia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061037 | PDS PLUS ANTIBACTERIAL SUTURE ETHICON, Inc., Jul 14, 2006 |