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

Products covered by this recall
#Product as published
1DRAPE % 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 (
2SUTURE 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 (
3CAUTERY TIP POLISHER (2) LITE GLOVES (
4YANKAUER SUCTION TUBE WITHOUT VENT (20) LAP SPONGE PREWASH 18 X 18 XRD (1) CAUTERY PENCIL ROCKER SWITCH WITH HOLSTER (1) UNDERPAD 23 X 36 (
5TUBE 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 900-2661
    • 1
  • 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 14, 2017 · Data as of Sep 19, 7:45 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.