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

Recall Z-2367-2014 — OB PACK - (1) BABY BLANKET PRINTED (1) BABY BEANIES (1) TABLE COVER REINFORCED 50" X 90" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) DRAPE UNDERBUTIOCK W/ POUCH 44" X 35" LIF (3) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE SHEET 41 " X 58" SMS LIF (2) PAD OBSTETRICAL X-LARGE LIF (1) RECEIVING

U.S. FDA — Device Enforcement · United States · 2014-05-20 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2367-2014
Date of alert
2014-05-20
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Customed, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
112041230
Reported risk: Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
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.