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Terminated

Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.

FDA Recall Z-2036-2021 · Posted None

Recalling FirmCardinal Health 200, LLC
Recall StatusTerminated
Product CodePUI
Date Initiated2021-05-21
Date Terminated2024-01-08
Product Quantity6461 units

Reason for Recall

The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.

Firm Action

The firm initiated the recall by letter on 05/20/2021. The letter explained the issue and the hazard, and requested the return of the units.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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