HIGADO & PANCREA PACK - (1) BAG SUTURE FLORAL (2) YANKAUER SUCTION TUBE WITHOUT VENT (4) DRAPE UTILITY WITH TAPE (6) TOWELS CLOTH HUCK BLUE (1) SHEET DRAPE 41 " X 58" SMS (1) MAYO TRAY LARGE (1) TABLE COVER REINFORCED 50" X 90" (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" (1) DRAPE BARIATRIC (1) BLADE SURGICAL #10 STAINLESS STEEL (1) CUP SPECIMEN WITH CAP 4oz (1) BLADE SURGICAL #15 STAINLESS STEEL (30) LAP SPONGE PREWASH 18" X 18" XRD (1) STRIP STERI CLOSURE W X 4" (1) POLISHER CAUTERY TIP (1) NEEDLE ECLIPSE 22 X 1 Y2 (4) TOWEL ABSORBENT 15" X 20" (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK (2) LITE GLOVE (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) COUNTER NDLE/BLADE 60C FOAM/STR/MAG/STR (1) FORCE TRIVERSE (1) SYRINGE BULB 60CC (1) BLADE EXTENDED ELECT. 16.51cm (2) TUBE SUCTION CONNECT Y." X 12' (2) CHLORAPREP 26ML APPLICATOR TEAL (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Enforcement
- Recall Number
- Z-2423-2014
- 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
HIGADO & PANCREA PACK - (1) BAG SUTURE FLORAL (2) YANKAUER SUCTION TUBE WITHOUT VENT (4) DRAPE UTILITY WITH TAPE (6) TOWELS CLOTH HUCK BLUE (1) SHEET DRAPE 41 " X 58" SMS (1) MAYO TRAY LARGE (1) TABLE COVER REINFORCED 50" X 90" (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" (1) DRAPE BARIATRIC (1) BLADE SURGICAL #10 STAINLESS STEEL (1) CUP SPECIMEN WITH CAP 4oz (1) BLADE SURGICAL #15 STAINLESS STEEL (30) LAP SPONGE PREWASH 18" X 18" XRD (1) STRIP STERI CLOSURE W X 4" (1) POLISHER CAUTERY TIP (1) NEEDLE ECLIPSE 22 X 1 Y2 (4) TOWEL ABSORBENT 15" X 20" (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK (2) LITE GLOVE (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) COUNTER NDLE/BLADE 60C FOAM/STR/MAG/STR (1) FORCE TRIVERSE (1) SYRINGE BULB 60CC (1) BLADE EXTENDED ELECT. 16.51cm (2) TUBE SUCTION CONNECT Y." X 12' (2) CHLORAPREP 26ML APPLICATOR TEAL (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE 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 900-1966, 18 lots: 113025951 113026188 113036672 113047210 113067907 113078582 113099405 113109642 113109776 131110111 131110333 131210639 140111088 140211806 140312102 140412625 140412892 140513119
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.
18 lots; 738 units (multiple units per lot)