FDAFDA · Food and drugs·Recall number Z-1571-2023
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
Published May 17, 2023 · Recall initiated: March 31, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Ethicon, Inc.
- Distributor
- International distribution in the countries of United Kingdom, Ireland and Turkey.
- Lot
- UDI-DI: (01)10705031124691 Primary (Individual Unit); (01)30705031124695 (Sales Unit Box) Qty = 36 eaches. Lot Number: SCMAZH
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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