LAPAROSCOPY PACK - ( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F ( 1) NEEDLE ULTRA VERES 120MM LIF ( 1) TROCAR ENDOPATH XCEL DILATING TIP (K11LT) LIF ( 1) TROCAR ENDO.XCEL DILATING TIP (KSLT) LIF (1) GOWN IMPERV. XTRA REINFORCED XL T/WRAP AAMI III (1) MAYO STAND COVER REINFORCED LIF (5) SPONGE LAP PREWASH 18" X 18" XRD LIF ( 1) CONTAINER SPECIMEN 40Z. WITH LID & LABEL LIF ( 1) BOWL UTILITY 16oz. LIF (1) SOLUTION SURGICAL DURAPREP 26ML ST. LIF (1) DRAPE LASER CAMERA W/EL 6" X 96" LIF (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (4) DRAPE UTILITY WITH TAPE LIF (4) TOWELS ABSORBENT 15" X 20" LIF (1) DRAPE ENDOSCOPY 100" X 123%" X 77" WITH TROUGHS L/F (2) SHEET DRAPE 42" X 57" SMS LIF (1) BLADE SURGICAL #11 STAINLESS STEEL ( 1) TIME OUT BEACON NON WOVEN ST L/F (6) GAUZE SPONGE 2" X 2" 4PL Y LIF ( 1) BLADE SURG. #15 CARBON STEEL ( 1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill LIF (1) TABLE COVER REINFORCED 50" X 90" L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Enforcement
- Recall Number
- Z-2424-2014
- Event ID
- 68536
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Customed, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 10, 2014
- Initiation Date
- May 20, 2014
- Classification Date
- August 29, 2014
- Termination Date
- August 14, 2017
- Address
- Calle Igualdad Final #7, Fajardo, PR, 00738, United States
Description
LAPAROSCOPY PACK - ( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F ( 1) NEEDLE ULTRA VERES 120MM LIF ( 1) TROCAR ENDOPATH XCEL DILATING TIP (K11LT) LIF ( 1) TROCAR ENDO.XCEL DILATING TIP (KSLT) LIF (1) GOWN IMPERV. XTRA REINFORCED XL T/WRAP AAMI III (1) MAYO STAND COVER REINFORCED LIF (5) SPONGE LAP PREWASH 18" X 18" XRD LIF ( 1) CONTAINER SPECIMEN 40Z. WITH LID & LABEL LIF ( 1) BOWL UTILITY 16oz. LIF (1) SOLUTION SURGICAL DURAPREP 26ML ST. LIF (1) DRAPE LASER CAMERA W/EL 6" X 96" LIF (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (4) DRAPE UTILITY WITH TAPE LIF (4) TOWELS ABSORBENT 15" X 20" LIF (1) DRAPE ENDOSCOPY 100" X 123%" X 77" WITH TROUGHS L/F (2) SHEET DRAPE 42" X 57" SMS LIF (1) BLADE SURGICAL #11 STAINLESS STEEL ( 1) TIME OUT BEACON NON WOVEN ST L/F (6) GAUZE SPONGE 2" X 2" 4PL Y LIF ( 1) BLADE SURG. #15 CARBON STEEL ( 1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill LIF (1) TABLE COVER REINFORCED 50" X 90" L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
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.
Product code 900-1967, 19 lots: 111123453 112030696 112041219 112041457 112051908 112062470 112083417 112125164 113015692 113025952 113026107 113026233 113047010 113057694 113078292 140211807 140312103 140412626 140412893
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.
19 lots; 351 units (multiple units per lot)