Recall Z-2327-2014

Customed, Inc · initiated May 20, 2014

Class I Terminated

Class I – dangerous or defective products that could cause serious health problems or death

Product

LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9" X 96" LIF (5) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50" X 90" (4) DRAPE UTILITY WITH TAPE (3) DRAPE SHEET 41" X 58" SMS (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR (5) LAP SPONGE PREWASH 18" X 18" XRD (1) GOWN LGE SMS IMPERVIOUS REINFORCED (2) GOWN X-LARGE SMS IMPERV. REINFORCED (2) MEDICINE CUP 2oz. (1) NEEDLE HYPODERMIC 18G X 1% ST. ( 1) BLADE SURG. # 15 CARBON STEEL (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR (1) DRESSING TEGADERM 4" X 4%" (1) SOLUTION SURGICAL DURAPREP 6mL (1) TRAY MAYO SMALL (1) TUBE SUCTION CONNECT. %"X 12' (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) NEEDLE ECLIPSE 22 X 1% (1) TIME OUT BEACON NON WOVEN ST EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents

Codes / lots: Product code 900-474, 19 lots: 112030843 112103944 112114393 112114480 112125096 113015452 113036801 113057847 113078330 113088867 113089075 113109844 131110262 131210818 140111232 140211671 140412469 140412888 140513480

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.

FDA-determined cause: Package design/selection

Action taken

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

Details

Recall number
Z-2327-2014
Initiated
May 20, 2014
Posted by FDA
August 29, 2014
Terminated
August 14, 2017
Product code
FDE – Laparoscopy Kit
Quantity
19 lots; 1168 units (multiple lots per unit)
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.
Recalling firm
Customed, Inc, Fajardo

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2302-2014 Class ICustomed Angiodrape Pack convenience pack include multiple components: syringe 10cc and…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2303-2014 Class ICustomed O.B. Pack convenience pack include multiple components: set up cover, absorbent…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2304-2014 Class ICustomed Laparoscopy convenience pack include multiple components: gowns, table covers…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2305-2014 Class ICustomed Major Laparotomy Pack , convenience pack include multiple components: Mayo…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2306-2014 Class ICustomed Cysto Tur Pack, convenience pack include multiple components: legging with…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2307-2014 Class ICustomed Laparotomy Pack , convenience pack include multiple components: drape laparot.…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2308-2014 Class ICustomed Femoral Pack , convenience pack include multiple components: Syringe 3cc, 5cc…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2309-2014 Class ICustomed LABOR & DELIVERY PACK - Includes: (1) TABLE COVER 44" x 90" (2) LEGGINS WITH/7"…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2310-2014 Class IUniversal Pack- - (1) TABLE COVER REINFORCED 50" X 90" LIF (3) TOWEL ABSORBENT 15" X 20"…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2311-2014 Class IOPEN HEART TRAY - PACK- (25) SPONGE LAP PREWASH 18" X 18" XRD L/F (1) TRAY PLATO LARGE…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2312-2014 Class ILAPAROTOMY PACK - CUSTOMED- (1) BAG SUTURE FLORAL (2) TOWEL ABSORBENT 15" X 20" (1) MAYO…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2313-2014 Class IANGIOGRAPHY PACK- - (4) CLOTH HUCK TOWEL BLUE UF (1) TABLE COVER REINFORCED 50" X 90"…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2314-2014 Class I0.B. PACK - HSCH- (1) PVP SCRUB 8" STICK SPONGES (1) UNDERBUTTOCK DRAPE WITH POUCH (2)…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2315-2014 Class ILAPAROTOMY PACK - (I) SURGICAL BLADE #10 S/STEEL ( I) UTILITY BOWL 32oz (I) UTILITY BOWL…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2316-2014 Class ILAPAROTOMY PACK - (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDPAD (I)…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2317-2014 Class IBASIC PACK W/OUT GOWN- (1) TABLE COVER REINFORCED 50" X 90" UF (4) DRAPE UTILITY WITH…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2318-2014 Class IOPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2319-2014 Class IANGIODRAPE PACK - - (1) GUIDEWIRE 0.035" X 150cm (2) SYRINGE 10ccWITHOUT NEEDLE LUER…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2320-2014 Class ICESAREAN PACK - - (7) TOWELS ABSORBENT 15" X 20" (2) SCALPEL WEIGHTED SAFETY #1 0 (1)…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2321-2014 Class IMAJOR LAP PACK - (1) TABLE COVER REINF. 50" X 90" 10) GUZE SPONGE 4" X 4" 16PLY XRD (1)…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2322-2014 Class ICESAREAN PACK - - (1) MAYO STAND COVER REINFORCED LIF (20) LAP SPONGES PRE-WASH XRD LIF…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2323-2014 Class ILAPAROSCOPY CHOLE PACK - - ( 1) STRIP STERI CLOSURE W' X 4" LIF ( 1) TABLE COVER…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2324-2014 Class ILABOR & DELIVERY PAC - 1) NEEDLE HYPODERMIC 18G X 1% ST. (2) DRAPE UNDERBUTTOCK WITH…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2325-2014 Class ICYSTO TUR PACK- - (1) UTILITY BOWL 32oz LIF (1) SPECIMEN CUP WITH CAP 4oz LIF (1 0)…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2326-2014 Class IMINOR LAPAROTOMY PACK - (1) DRAPE T LAPAROTOMY (1) BAG SUTURE FLORAL LIF (4) DRAPE…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2328-2014 Class ILAPAROSCOPY~OBPACK - (4) ABSORBENT TOWELS 15" x 20" LIF (2) LEGGINS WITH 7" CUFF (1)…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2329-2014 Class ILAPAROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (2) DRAPE % ECONOMY 53" X 77"…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2330-2014 Class ILAPAROTOMY BASIC PACK- CUSTOMED- (1) TABLE COVER REINFORCED 44" X 78" LIF (1) COVER MAYO…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2331-2014 Class IPERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" UF (2) TOWEL ABSORBENT 15" X 20"…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated
Z-2332-2014 Class IPERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) DRAPE UTILITY (2) TOWELS…Customed has determined that there is the possibility that packaging integrity may be compromised on… 05/20/2014Terminated