Recall MonitorHealth Products
Perma-Sharp Sutures
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
Product: Perma-Sharp Sutures
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Perma Sharp Dyed Braided Silk Sutures With SS Needles - Parafilm Coated | 0126007HF | PSN7772S |
| Perma Sharp Dyed Braided Silk Sutures With SS Needles - Parafilm Coated | 0124002HF | PSN683S |
| Perma Sharp Dyed Braided Silk Sutures With SS Needles - Parafilm Coated | 0125037HF | PSN7772S |
| Perma Sharp Dyed Braided Silk Sutures With SS Needles - Parafilm Coated | 0125010HF | PSN683S |
| Perma Sharp Dyed Braided Silk Sutures With SS Needles - Parafilm Coated | 0125005HF | PSN7772S |
| Perma Sharp Dyed Braided Silk Sutures With SS Needles - Parafilm Coated | 0125028HF | PSN7772S |
| Perma Sharp Dyed Braided Silk Sutures With SS Needles - Parafilm Coated | 0124001HF | PSN683S |
| Perma Sharp Polypropylene Dyed Mono Filament With SS Needle | 0625002HF | PSN8384P |
| Perma Sharp Polypropylene Dyed Mono Filament With SS Needle | 0625001HF | PSN8384P |
| Perma Sharp Polypropylene Dyed Mono Filament With SS Needle | 0624010HF | PSN8695P |
| Perma Sharp Polypropylene Dyed Mono Filament With SS Needle | 0624002HF | PSN8384P |
| Perma Sharp Polypropylene Dyed Mono Filament With SS Needle | 0624014HF | PSN8698P |
| Perma Sharp Polypropylene Dyed Mono Filament With SS Needle | 0625016HF | PSN8695P |
| Perma Sharp Polypropylene Dyed Mono Filament With SS Needle | 0624001HF | PSN8695P |
| Perma Sharp PGA Suture Braided Undyed With Stainless Steel Wire - Coated | 0925025HF | PSN393V |
| Perma Sharp PGA Suture Braided Undyed With Stainless Steel Wire - Coated | 0925032HF | PSN392V |
| Perma Sharp PGA Suture Braided Undyed With Stainless Steel Wire - Coated | 0925013HF | PSN397V |
| Perma Sharp PGA Suture Braided Undyed With Stainless Steel Wire - Coated | 0924006HF | PSN392V |
| Perma Sharp PGA Suture Braided Undyed With Stainless Steel Wire - Coated | 0924005HF | PSN392V |
| Perma Sharp PGA Suture Braided Undyed With Stainless Steel Wire - Coated | 0924007HF | PSN392V |
| Perma Sharp PGA Suture Braided Undyed With Stainless Steel Wire - Coated | 0125005HF | PSN392V |
| Perma Sharp PGA Suture Braided Violet With Stainless Steel Wire - Coated | 0925026HF | PSN385V |
| Perma Sharp PGA Suture Braided Violet With Stainless Steel Wire - Coated | 0925014HF | PSN385V |
| Perma Sharp PGA Suture Braided Violet With Stainless Steel Wire - Coated | 0925031HF | PSN385V |
| Perma Sharp PGA Suture Braided Violet With Stainless Steel Wire - Coated | 0924017HF | PSN421V |
Issue
Perma-sharp sutures are manufactured for Hu-Friedy by 2 manufacturers. 1. Surgical Specialties Corporation has cleared for the U.S. market & 2. Camark SA are authorized for the European Union, United Kingdom, Switzerland, & Israel. Products have same commercial item number regardless of manufacturer. Henry Schein Inc. has determined that Perma-sharp sutures manufactured for Hu-Friedy by Camark SA were incorrectly distributed in the United States, Canada, Cayman Islands and Uganda.