FDAFDA · Food and drugs·Recall number Z-2147-2024
PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: PDP304H PDP316H PDP341H
Published June 26, 2024 · Recall initiated: May 10, 2024
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
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ethicon, Inc.
- Distributor
- Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.
- Lot
- GTIN: 10705031047976 10705031048027 10705031048119 PRODUCT CODE PRODUCT LOTS PDP304H TLMJLZ PDP316H UAMKDC PDP341H UBMCZA
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.