Reported Sep 10, 2014 · Terminated
Breast Pack MRT, code 900-2658, contains
Customed, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Customed, Inc · Calle Igualdad Final #7 · Fajardo, PR · 00738
Is this the product you have?
Breast Pack MRT, code 900-2658, contains
11 of 11 products
| # | Product as published |
|---|---|
| 1 | BULB SYRINGE 60cc (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( |
| 2 | CAUTERY PENCIL PUSH BOTTOM (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK ( |
| 3 | NEEDLE and BLADE COUNTER 20c FOAM/MAG ( |
| 4 | UTILITY BOWL QUART 32oz ( |
| 5 | MAYO STAND COVER REINFORCED ( |
| 6 | TABLE COVER REINFORCED 50 X 90 ( |
| 7 | DRAPE BREAST/CHEST SMS ( |
| 8 | YANKAUER SUCTION TUBE W/0 VENT ( |
| 9 | TUBE SUCTION CONNECT Y ( |
| 10 | RULER 6 CLEAR (6) TOWEL CLOTH HUCK C (BLUE) (2) TOWEL ABSORBENT 15 X 20 (2) SKIN MARKER INK W/ LABEL ( |
| 11 | 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. |
- Lot codes and dates
Code 900-26583 lots 112062217 112093595 112093720
- Amount recalled
- 3 lots, 306 units, multiple units per lot
This recall covers 233 products
The agency filed one notice per product. You are reading one of them; the other 232 are below.
220 more are in the archive.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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