PlainRecalls
FDA Devices Critical Class I Terminated

PERl GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (2) TOWELS ABSORBENT 15" X 20" UF (1) TOP DRAPE WITH ADHESIVE STD SMS (1) CATHETER NELATON ROB. 14FR. (2) GOWN IMPERVIOUS EXTRA REINFORCED XL (1) UNDERBUITOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" X 42" (1) TABLE COVER REINFORCED 44" X 78" UF (1 0) GAUZE SPONGES 4" X 4" 16PL Y XRD LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Reported: September 10, 2014 Initiated: May 20, 2014 #Z-2370-2014

Product Description

PERl GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (2) TOWELS ABSORBENT 15" X 20" UF (1) TOP DRAPE WITH ADHESIVE STD SMS (1) CATHETER NELATON ROB. 14FR. (2) GOWN IMPERVIOUS EXTRA REINFORCED XL (1) UNDERBUITOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" X 42" (1) TABLE COVER REINFORCED 44" X 78" UF (1 0) GAUZE SPONGES 4" X 4" 16PL Y XRD LIF 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
43 lots; 3201units (multiple units per lot)
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? ▼
PERl GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (2) TOWELS ABSORBENT 15" X 20" UF (1) TOP DRAPE WITH ADHESIVE STD SMS (1) CATHETER NELATON ROB. 14FR. (2) GOWN IMPERVIOUS EXTRA REINFORCED XL (1) UNDERBUITOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" X 42" (1) TABLE COVER REINFORCED 44" X 78" UF (1 0) GAUZE SPONGES 4" X 4" 16PL Y XRD LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.. Recalled by Customed, Inc. Units affected: 43 lots; 3201units (multiple units per lot).
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-2370-2014.

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