PlainRecalls
FDA Devices Critical Class I Terminated

Lithotomy Pack III (3), code 900-2487, contains: (3) TOWEL ABSORBENT 15" X 20" (1) GOWN LARGE STANDARD SMS VELCRO NECK (2) LEGGINS WITH 7" CUFF 30" X 42" (1) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35" (1) DRAPE ABDOMINAL WITH TAPE 40" X 54" (1) DRAPE UTILITY WITH TAPE (1) COVER TABLE REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Reported: September 10, 2014 Initiated: May 20, 2014 #Z-2534-2014

Product Description

Lithotomy Pack III (3), code 900-2487, contains: (3) TOWEL ABSORBENT 15" X 20" (1) GOWN LARGE STANDARD SMS VELCRO NECK (2) LEGGINS WITH 7" CUFF 30" X 42" (1) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35" (1) DRAPE ABDOMINAL WITH TAPE 40" X 54" (1) DRAPE UTILITY WITH TAPE (1) COVER TABLE REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Reason for Recall

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.

Details

Recalling Firm
Customed, Inc
Units Affected
0 distributed; 300 packed units manufactured under firm's control
Distribution
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
Location
Fajardo, PR

Frequently Asked Questions

What product was recalled? ▼
Lithotomy Pack III (3), code 900-2487, contains: (3) TOWEL ABSORBENT 15" X 20" (1) GOWN LARGE STANDARD SMS VELCRO NECK (2) LEGGINS WITH 7" CUFF 30" X 42" (1) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35" (1) DRAPE ABDOMINAL WITH TAPE 40" X 54" (1) DRAPE UTILITY WITH TAPE (1) COVER TABLE REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.. Recalled by Customed, Inc. Units affected: 0 distributed; 300 packed units manufactured under firm's control.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 10, 2014. Severity: Critical. Recall number: Z-2534-2014.

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