CP Medical Inc: Medical Device Recall in 2019 - (Recall #: Z-1027-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural tissues.

Product Classification:

Class II

Date Initiated: February 4, 2019

Date Posted: March 27, 2019

Recall Number: Z-1027-2019

Event ID: 82197

Reason for Recall:

Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.

Status: Ongoing

Product Quantity: 1,905 boxes (22,860 sutures total)

Code Information:

Product Code (lot code): 822PG-HUF (170927-52, 180611-59); 822PG-DAR (171205-52); 810PG-1 (180924-51); 822PG-1 (180924-53)

Distribution Pattern:

Worldwide Distribution - US Nationwide to IA, IL, NY, SC. Distributed internationally to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated