Recall Z-2330-2014
Customed, Inc · initiated May 20, 2014
Class I – dangerous or defective products that could cause serious health problems or death
Product
LAPAROTOMY BASIC PACK- CUSTOMED- (1) TABLE COVER REINFORCED 44" X 78" LIF (1) COVER MAYO STAND REINFORCED UF (2) TOWEL ABSORBENT 15" X 20" UF (1 0) GAUZE SPONGES XRD 4" X 4"-12PL Y (2) DRAPE SHEET 41 " X 58" SMS UF (4) DRAPE UTILITY WITH TAPE L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
Codes / lots: Product code 900-547, 19 lots: 109010180 109030602 110020394 110041044 110061584 110071846 110112813 111030690 111102881 112020520 112030884 112051719 112083433 113025793 113036491 113046966 113057746 140111076 140312175
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-2330-2014
- Initiated
- May 20, 2014
- Posted by FDA
- August 29, 2014
- Terminated
- August 14, 2017
- Product code
- FHI – Ring, Laparotomy
- Quantity
- 19 lots; 550 units (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.
- Recalling firm
- Customed, Inc, Fajardo
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2302-2014 Class I | Customed 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 I | Customed 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 I | Customed 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 I | Customed 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 I | Customed 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 I | Customed 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 I | Customed 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 I | Customed 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 I | Universal 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 I | OPEN 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 I | LAPAROTOMY 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 I | ANGIOGRAPHY 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 I | 0.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 I | LAPAROTOMY 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 I | LAPAROTOMY 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 I | BASIC 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 I | OPHTALMIC 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 I | ANGIODRAPE 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 I | CESAREAN 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 I | MAJOR 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 I | CESAREAN 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 I | LAPAROSCOPY 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 I | LABOR & 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 I | CYSTO 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 I | MINOR 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-2327-2014 Class I | LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9" X 96" LIF (5)…Customed has determined that there is the possibility that packaging integrity may be compromised on… | 05/20/2014Terminated |
| Z-2328-2014 Class I | LAPAROSCOPY~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 I | LAPAROSCOPY 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-2331-2014 Class I | PERY 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 I | PERY 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 |