Recall Z-2491-2014— Customed, Inc
Class I · Terminated
Class I FDA medical device recall by Customed, Inc, initiated 2014-05-20, terminated 2017-08-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Breast Pack MRT, code 900-2658, contains: ( 1) BULB SYRINGE 60cc (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK ( 1) NEEDLE and BLADE COUNTER 20c FOAM/MAG ( 1) UTILITY BOWL QUART 32oz ( 1) MAYO STAND COVER REINFORCED ( 1) TABLE COVER REINFORCED 50 X 90 ( 1) DRAPE BREAST/CHEST SMS ( 1) YANKAUER SUCTION TUBE W/0 VENT ( 1) TUBE SUCTION CONNECT Y ( 1) RULER 6 CLEAR (6) TOWEL CLOTH HUCK C (BLUE) (2) TOWEL ABSORBENT 15 X 20 (2) SKIN MARKER INK W/ LABEL ( 1) DENTURE CUP 8oz W/LID (2) LITE GLOVES Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.. Reason: 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..
- Recalling firm
- Customed, Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-05-20
- Terminated
- 2017-08-14
- Firm location
- Fajardo, PR, United States
Product description
Breast Pack MRT, code 900-2658, contains: ( 1) BULB SYRINGE 60cc (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK ( 1) NEEDLE and BLADE COUNTER 20c FOAM/MAG ( 1) UTILITY BOWL QUART 32oz ( 1) MAYO STAND COVER REINFORCED ( 1) TABLE COVER REINFORCED 50 X 90 ( 1) DRAPE BREAST/CHEST SMS ( 1) YANKAUER SUCTION TUBE W/0 VENT ( 1) TUBE SUCTION CONNECT Y ( 1) RULER 6 CLEAR (6) TOWEL CLOTH HUCK C (BLUE) (2) TOWEL ABSORBENT 15 X 20 (2) SKIN MARKER INK W/ LABEL ( 1) DENTURE CUP 8oz W/LID (2) LITE GLOVES Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
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.
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