Medline Recalls Surgical Gowns, Packs, and Drapes Due to Sterilization Concerns

What Happened

Medline Industries, LP has identified calibration issues linked to the equipment used to sterilize various surgical gowns, packs, and drapes. This defect impacts the sterility assurance level of the products, creating a risk that non-sterile devices may be placed within a sterile field or used during sterile medical procedures. Such use could lead to contamination and potential patient infection.

Which Products Are Affected

The recall affects several Medline kits and packs. Specific models and lot numbers include:

• Simple Neck Dissection: Lot 21BBP023 (Model DYNJ47481C)
• Ortho - ACL Pack: Lots 25CBJ143, 25ABK343, 24FBF369, 24LBN605 (Model DYNJ51249B)
• Liver-Kidney Pack LF: Lot 20LBW807 (Model DYNJ38251B)
• Vasc - AAA - LF: Lot 23ABI719 (Model DYNJ41839C)
• Cardio - Open Heart Bypass-LF: Lot 23ABB558 (Model DYNJ41835G)
• Hej-ENS Carnio Tumeur-LF: Lot 22OBC403 (Model DYNJ56840B)
• Ensemble Gyne Laparotomie-LF: Lot 23DBD093 (Model DYNJ47550C)
• Hip Pack: Lot 22LBR516 (Model DYNJ41692F)
• New Tissue Retrieval MH: Model DYNJ903849B (Multiple lots affected; contact manufacturer for details)

What You Should Do

Healthcare providers and customers are instructed to immediately quarantine all affected kit lot numbers. Medline has indicated that customers will be provided with over-labels for the affected products. For products with numerous affected lots, such as the New Tissue Retrieval MH, customers should contact Medline Industries, LP directly for a comprehensive list of affected serial numbers.

Why This Matters

The use of compromised surgical equipment in a sterile environment poses a significant health risk, as it can introduce pathogens directly into a patient’s body, leading to serious infections or surgical complications.

Source

Health Canada