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

Recall Z-2640-2024 — Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).

U.S. FDA — Device Enforcement · United States · 2024-06-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2640-2024
Date of alert: 2024-06-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Microtek Medical Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00748426002399

Reported risk: During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

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

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Recall Z-2640-2024 — Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).

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