Ethicon, Inc. Recall 92084
Description: PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H
Ethicon, Inc. Recall 92084 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1571-2023 |
| Event ID | 92084 |
| Event Description | PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H |
| Product Type | Devices |
| Distribution | International distribution in the countries of United Kingdom, Ireland and Turkey. |
| Quantity | 1,656 eaches (OUS only) |
| Recall Reason | Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved |
| Device Classification | 20230517 |
| Device Code Info | UDI-DI: (01)10705031124691 Primary (Individual Unit); (01)30705031124695 (Sales Unit Box) Qty = 36 eaches. Lot Number: SCMAZH |
| Center Classification Date | 20230510 |
| Recall Initiation Date | 20230331 |
| Recalling Firm | Ethicon, Inc. |
| Initial Notification | |
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