Henry Schein Perma Sharp sutures recalled for lack of 510(k) clearance
Henry Schein Inc. is recalling Perma Sharp sterile absorbable PGA surgical sutures (model PSN388V, HSI Item No. 600-8803) because the products lack FDA 510(k) clearance. The recall covers 27 units in lots 0924004HF and 0925023HF, distributed in the U.S. and in Canada, Uganda, and the Cayman Islands. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Stop using lots 0924004HF and 0925023HF and set them aside.
- Check the model number PSN388V (HSI Item No. 600-8803) and UDI-DI 10889950001261 on the package to confirm the product.
- The notice doesn't say how to get a refund or replacement; contact Henry Schein Inc. for next steps.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Generic Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN388V (HSI Item No. 600-8803); Product Description: Sterile, synthetic, absorbable, braided 5-0 violet polyglycolic acid (PGA) surgical suture, 18-inch length, with C-22 16.2 mm, 3/8-circle reverse-cutting needle. Component: N/A;
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 13 products — see all of them.
Details
- Units affected
- 27
- Illnesses reported
- None reported
- Manufactured in
- 41 Weaver Rd, Denver, Pennsylvania, United States
- Classification
- Class II
- Recall number
- Z-0343-2027
In the FDA's words
- Description
- Generic Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN388V (HSI Item No. 600-8803); Product Description: Sterile, synthetic, absorbable, braided 5-0 violet polyglycolic acid (PGA) surgical suture, 18-inch length, with C-22 16.2 mm, 3/8-circle reverse-cutting needle. Component: N/A; Products lack 510(k) clearance. Model/Catalog Number: PSN388V (HSI Item No. 600-8803); UDI-DI: 10889950001261; Lot Numbers: 0924004HF, 0925023HF; Distribution: Worldwide distribution - U.S. Nationwide and the countries of Canada, Uganda, and the Cayman Islands. Affected quantity: 27
- Hazard
- Products lack 510(k) clearance.
13 products in this recall
Henry Schein Perma Sharp sutures recalled for lacking 510(k) clearance
Henry Schein is recalling 13 Perma Sharp surgical suture products, sold under Henry Schein and HSI item numbers, because the products lack 510(k) clearance from FDA. The recall covers U.S. nationwide distribution and shipments to Canada, Uganda, and the Cayman Islands. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Generic Name: Perma Sharp Sutures;
Generic Name: Polypropylene Suture;
Model/Catalog Number: PSN8696P (Henry Schein Item No. 600-0115);
Product Descriptio…Z-0334-2027 · 10
- Generic Name: Perma Sharp Sutures;
Generic Name: PGA Absorbable Surgical Suture;
Model/Catalog Number: PSN397V (Henry Schein Item No. 600-0331);
Product D…Z-0335-2027 · 21
- Generic Name: Perma Sharp Sutures;
Generic Name: Silk Nonabsorbable Surgical Suture;
Model/Catalog Number: PSN7772S (HSI Item No. 600-3090);
Product Descr…Z-0336-2027 · 33
- Generic Name: Perma Sharp Sutures;
Generic Name: Silk Nonabsorbable Surgical Suture;
Model/Catalog Number: PSN632S (HSI Item No. 600-3506);
Product Descri…Z-0337-2027 · 20
- Generic Name: Perma Sharp Sutures;
Generic Name: Polypropylene Nonabsorbable Surgical Suture;
Model/Catalog Number: PSN8698P (HSI Item No. 600-5659);
Prod…Z-0338-2027 · 33
- Generic Name: Perma Sharp Sutures;
Generic Name: Silk Nonabsorbable Surgical Suture;
Model/Catalog Number: PSN683S (HSI Item No. 600-6411);
Product Descri…Z-0339-2027 · 140
- Generic Name: Perma Sharp Sutures;
Generic Name: PGA Absorbable Surgical Suture;
Model/Catalog Number: PSN421V (HSI Item No. 600-6870);
Product Descriptio…Z-0340-2027 · 11
- Generic Name: Perma Sharp Sutures;
Generic Name: Polypropylene Nonabsorbable Surgical Suture;
Model/Catalog Number: PSN8660P (HSI Item No. 600-7193);
Prod…Z-0341-2027 · 73
- Generic Name: Perma Sharp Sutures;
Generic Name: Polypropylene Nonabsorbable Surgical Suture;
Model/Catalog Number: PSN8384P (HSI Item No. 600-7664);
Prod…Z-0342-2027 · 137
- Generic Name: Perma Sharp Sutures;
Generic Name: PGA Absorbable Surgical Suture;
Model/Catalog Number: PSN388V (HSI Item No. 600-8803);
Product Descriptio… (this page)Z-0343-2027 · 27
- Generic Name: Perma Sharp Sutures;
Generic Name: PGA Absorbable Surgical Suture;
Model/Catalog Number: PSN392V (HSI Item No. 600-9613);
Product Descriptio…Z-0344-2027 · 472
- Generic Name: Perma Sharp Sutures;
Generic Name: PGA Absorbable Surgical Suture;
Model/Catalog Number: PSN387V (HSI Item No. 600-9683);
Product Descriptio…Z-0345-2027 · 16
- Generic Name: Perma Sharp Sutures;
Generic Name: Polypropylene Nonabsorbable Surgical Suture;
Model/Catalog Number: PSN8695P (HSI Item No. 600-9795);
Prod…Z-0346-2027 · 23