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.

LAPAROSCOPY PACK - ( 1) APPLIER MULTI CLIP WITH SHAF 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

LAPAROSCOPY PACK - ( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F ( 1) NEEDLE ULTRA VERES 120MM LIF ( 1) TROCAR ENDOPATH XCEL DILATING TIP (K11LT) LIF ( 1) TROCAR ENDO.XCEL DILATING TIP (KSLT) LIF (1) GOWN IMPERV. XTRA REINFORCED XL T/WRAP AAMI III (1) MAYO STAND COVER REINFORCED LIF (5) SPONGE LAP PREWASH 18" X 18" XRD LIF ( 1) CONTAINER SPECIMEN 40Z. WITH LID & LABEL LIF ( 1) BOWL UTILITY 16oz. LIF (1) SOLUTION SURGICAL DURAPREP 26ML ST. LIF (1) DRAPE LASER CAMERA W/EL 6" X 96" LIF (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (4) DRAPE UTILITY WITH TAPE LIF (4) TOWELS ABSORBENT 15" X 20" LIF (1) DRAPE ENDOSCOPY 100" X 123%" X 77" WITH TROUGHS L/F (2) SHEET DRAPE 42" X 57" SMS LIF (1) BLADE SURGICAL #11 STAINLESS STEEL ( 1) TIME OUT BEACON NON WOVEN ST L/F (6) GAUZE SPONGE 2" X 2" 4PL Y LIF ( 1) BLADE SURG. #15 CARBON STEEL ( 1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill LIF (1) TABLE COVER REINFORCED 50" X 90" L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Quantity: 19 lots; 351 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