Mckesson recalls GYNECATH H/S Catheters 5FR (10/CS) Model 11-19610 from June 2021-August 2021 due to potential temperature exposure affecting product effectiveness. Consumers should check their purchase date and contact Mckesson for details.
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.
Mckesson is recalling GYNECATH H/S Catheters 5FR (10/CS) Model 11-19610 that were shipped between June 1 and September 30, 2021. These catheters may have been exposed to higher temperatures during shipping, which could reduce their effectiveness. This recall does not pose a risk of injury but requires checking if your catheter was in the affected shipment period.
The catheters were shipped between June 1 and September 30, 2021, and may have been exposed to higher temperatures during transit. This temperature exposure could potentially reduce the product's effectiveness, but it does not cause injury or harm directly.
Healthcare facilities that received the catheters between June 1 and September 30, 2021. Patients using these catheters during that time may be at risk if the product was affected by temperature exposure.
Check if your catheter has the model number 11-19610 and was purchased between June 1 and September 30, 2021. The product was shipped to healthcare facilities during this period.
Verify your catheter's model number is 11-19610 and was shipped between June 1 and September 30, 2021.
The catheters may have been exposed to higher temperatures during shipping from June 2021 to August 2021, which could reduce their effectiveness.
No, this recall does not require stopping use. The issue is about potential reduced effectiveness, not injury risk.
Check if your catheter has model number 11-19610 and was shipped between June 1 and September 30, 2021.
We’ve drafted a message you can send Mckesson to request your refund or repair — edit it as you like.
Subject: Recall Z-1613-2022 — Mckesson Mckesson Hello, I own a Mckesson that is covered by recall Z-1613-2022 from Mckesson. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
