Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2224-2024 — Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. b. Medline Angiography Pack, Pack #DYNJ26488W, containing a Pure Pouch with component Medline Reorder

U.S. FDA — Device Enforcement · United States · 2024-03-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2224-2024
Date of alert: 2024-03-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: MEDLINE INDUSTRIES, LP - Northfield
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10195327195618

Reported risk: Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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