Mckesson Medical-Surgical Inc. Corporate Office: Medical Device Recall in 2022 - (Recall #: Z-1613-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610

Product Classification:

Class II

Date Initiated: May 25, 2022

Date Posted: August 31, 2022

Recall Number: Z-1613-2022

Event ID: 90336

Reason for Recall:

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Status: Ongoing

Product Quantity: a. 30 each b. 0.3 cs

Code Information:

GTIN: a. 20612479161539; 30612479162472 BX; 40612479161571 CS. b. 20612479161546; 30612479162489 BX; 40612479161588 CS

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated