Recall Z-1136-2019 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
Ethicon, Inc.
PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable sutur
| Date | Mar 12, 2019 |
| Status | Terminated |
| Reason | VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label. |
| Root cause | Packaging process control |
| Action | Ethicon notified primary and secondary US consignees via UPS second day between March 12-15,2019. Receipt of the letter confirmed via UPS tracking. Ethicon Johnson & Johnson Affiliates in North America (Canada), Europe, Middle East. Latin America and Asia Pacific will notify their impacted consignees by providing the customer letter through post, email or sales representative visits. The letter describes the problem and action to take:Examine your inventory immediately to determine if you have product subject to this recall (removal) on hand and quarantine such product(s). Remove the product |
| Quantity | 550,681 eaches (WW) Total |
| Distribution | Worldwide distributions - US Nationwide and countries of AUSTRALIA BELGIUM CANADA CHINA ISRAEL JAPAN PUERTO RICO SINGAPORE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.