Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

BASIC COSMETIC SURG. PACK CUSTOMED (USA) Recalled by Customed, Inc Due to Customed has determined that there is the possibility...

Date: May 20, 2014
Company: Customed, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Customed, Inc directly.

Affected Products

BASIC COSMETIC SURG. PACK CUSTOMED (USA), CODE 900-2915. CONTENTS: (2) TOWELS ABSORBENT 15" X 20" LIF (1) DRAPE BREAST/CHEST SMS L/F (1) SYRINGE 20cc W/0 NEEDLE LUER LOCK LIF (1) TUBE SUCTION CONNECT Yt" X 12' LIF (1) YANKAUER SUCTION TUBE W/0 VENT L/F (1) STERI STRIP CLOSURE%" X 4" L/F (1) BLADE SURG. #15 CARBON STEEL (1) NEEDLE HYPODERMIC 25 X 1 % LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) PENCIL CAUTERY ROCKER SWITCH W/ HOLSTER LIF (1) SYRINGE 60cc THUMB CONT. RING CATH. TIP LIF (1) COVER TABLE REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (1) BAG SUTURE FLORAL (2) GOWN SOFT SMS STD. XL SET IN SLEEVE LIF (4) DRAPE UTILITY WITH TAPE L/F (4) TOWEL CLOTH HUCK LIF (1) WRAPPER 24" X 24" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Quantity: 4 lots, 168 units ( multiple units per lot)

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Customed, Inc

Customed, Inc has 682 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report