Reported Sep 10, 2014 · Terminated
Tummy Tuck and Liposuction Pack, code 900-2661, 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?
Tummy Tuck and Liposuction Pack, code 900-2661, contains
5 of 5 products
| # | Product as published |
|---|---|
| 1 | DRAPE % ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD X-LARGE SET IN SLEEVE (3) TOWELS ABSORBENT 15 X 20 (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50 X 90 ( |
| 2 | SUTURE BAG FLORAL (6) TOWEL CLOTH HUCK BLUE (1) BLADE SURGICAL CARBON STEEL 10 (1) BLADE SURGICAL CARBON STEEL 11 (4) PAD ABDOMINAL 8 X 7.5 ( |
| 3 | CAUTERY TIP POLISHER (2) LITE GLOVES ( |
| 4 | YANKAUER SUCTION TUBE WITHOUT VENT (20) LAP SPONGE PREWASH 18 X 18 XRD (1) CAUTERY PENCIL ROCKER SWITCH WITH HOLSTER (1) UNDERPAD 23 X 36 ( |
| 5 | TUBE SUCTION CONNECT 1/4 X 12 (1) DRAPE BREAST/CHEST SMS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
- Lot codes and dates
Code 900-26611
- lot140312417
- Amount recalled
- 1 lot/12 units
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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