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

Face Pack MRT, product code 900-2654, contains: (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF (2) TOWELS ABSORBENT 15 X 20 LIF (1) DRAPE INST. MAGNETIC 10 X 16 LIF (1) TRAY HALF DEEP (1) COVER MAYO STAND REINFORCED LIF (1) SHEET ENT SPLIT 110 X 77 SMS LIF (1) COVER TABLE REINFORCED 44" X 78 — recall Z-2488-2014

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-2488-2014
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)
112062214
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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

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