Medline recalls catheter insertion trays produced between June 1, 2021 and September 30, 2021 due to potential temperature excursions affecting product effectiveness.
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.
Medline is recalling catheter insertion trays made between June 1 and September 30, 2021 because they may have been exposed to higher temperatures during shipping, which could reduce their effectiveness. This recall affects healthcare facilities that received these trays during the specified period.
The trays may have been exposed to higher temperatures during shipping from June to August 2021, which could impact their effectiveness. This is a potential issue for medical devices that require precise temperature control to function properly.
Healthcare facilities that received Medline catheter insertion trays between June 1 and September 30, 2021 are most at risk. These trays are used in medical settings for catheter procedures.
Check for Medline catheter insertion trays with model number DYND10160 or GTIN 10080196997091/40080196997092. These were produced between June 1 and September 30, 2021.
Identify the model number (DYND10160) or GTIN (10080196997091 or 40080196997092) on the tray.
The recall is due to potential temperature excursions during shipping from June to August 2021, which may have impacted the product's effectiveness.
These trays were produced between June 1 and September 30, 2021.
The recall does not specify a remedy, so contact Medline directly for guidance.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1609-2022 — Medline Medline Hello, I own a Medline that is covered by recall Z-1609-2022 from Medline. 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.
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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.
