Health product recall

Perma Sharp Plain Absorbable Gut Suture with Needles, Perma Sharp Plain Gut Natural Collagen Absorbable Suture (2019-02-14)

Starting date:
February 14, 2019
Posting date:
March 15, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69280

Affected Products

  1. Perma Sharp Plain Absorbable Gut Suture with Needles
  2. Perma Sharp Plain Gut Natural Collagen Absorbable Suture

Reason

Routine monitoring of plain gut sutures not released to market exceeded endotoxin limits. As a precaution, suture lots manufactured from the same raw material lot are being recalled. There have been no complaints associated with the lots being recalled.

Affected products

A. Perma Sharp Plain Absorbable Gut Suture with Needles

Lot or serial number
  • 170927-52
  • 180611-59
Model or catalog number

PSNH822A

Companies
Manufacturer

HU-FRIEDY MFG. CO., LLC

3232 N. ROCKWELL ST

Chicago

60618

Illinois

UNITED STATES


B. Perma Sharp Plain Gut Natural Collagen Absorbable Suture

Lot or serial number
  • 170927-52
  • 180611-59
Model or catalog number

63-B822PG-01

Companies
Manufacturer

HU-FRIEDY MFG. CO., LLC

3232 N. ROCKWELL ST

Chicago

60618

Illinois

UNITED STATES