Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling GYNECATH H/S CATHETER 5FR products due to temperature excursions that occurred at a facility between June and August 2021, before the products were delivered. The exposure to higher temperatures may have affected the catheters' effectiveness. The recall affects all lots received between June 1, 2021 and September 30, 2021, and was distributed nationwide.
The affected products are identified by specific GTINs and lot codes provided in the recall notice. According to the source document, no remedy information is specified for consumers or healthcare facilities that received these catheters.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US Nationwide Quantity: a. 30 each b. 0.3 cs Lot/code info: GTIN: a. 20612479161539; 30612479162472 BX; 40612479161571 CS. b. 20612479161546; 30612479162489 BX; 40612479161588 CS
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.