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[Recalled] CESAREAN PACK - (1) BABY BLANKET IMP. 30" X 30" POLY ABS. (1) NEEDLE & BLADE COUNTER 60c FOAM/STRIP MAG/STRIP LIF (1) DRESSING ISLAND 4" x 10" (1) CESAREAN DRAPE 71" x 125" LIF (2) GOWN SURG REINFORCED LARGE TOWEL/WRAP (10

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductCESAREAN PACK - (1) BABY BLANKET IMP. 30" X 30" POLY ABS. (1) NEEDLE & BLADE COUNTER 60c FOAM/STRIP MAG/STRIP LIF (1) DRESSING ISLAND 4" x 10" (1) CESAREAN DRAPE 71" x 125" LIF (2) GOWN SURG REINFORCED LARGE TOWEL/WRAP (10) LAP SPONGES PREWASH XRD LIF (1) BABY BEANNIES (1) SCALPEL #10 WITH
Brand / manufacturerCustomed, Inc
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2405-2014
Country of noticeUnited States
Risk levelClass I
Hazard typerecall
Notice date20 May 2014
EAN / barcode111113026

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).

Read the full official notice →

Related recalls from Customed, Inc

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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