—#129264

Product

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.

FDA product code: OKV — Obstetrical Kit
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: Product code 900-1061, 43 lots: 110051144 110061480 110071614 110082107 110102421 110112595 110123081 111010014 111020502 111030541 111030814 111040868 111061579 111071751 111082041 111082267 111092342 111102654 111112942 112020305 112051670 112062315 112072764 112083153 112093849 113025926 113026038 113036447 113046995 113047194 113057377 113057824 113068139 113078455 113099265 113099585 131110150 131210675 131211024 140311916 140312431 140412826 140513473

Why it was 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.

Root cause (FDA determination)

Package design/selection

Action the firm took

Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit. Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540

Recalling firm

Firm: Customed, Inc Calle Igualdad Final # 7
Address: Fajardo, Puerto Rico 00738

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2014-05-20
Posted by FDA: 2014-08-29
Terminated: 2017-08-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129264. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.