Agency classClass IOur severity:Severe FDA (Devices)·Z-2524-2014·Announced 2014-09-10

Customed Recalls Tummy Tuck Surgical Packs Due to Packaging Integrity Concerns

Customed, Inc. is recalling Tummy Tuck surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states the agency classification is Class I. According to the rubric, if the agency's own classification is FDA Class I, the score must never go below 4. Additionally, the potential for loss of sterility in surgical packs is a significant injury risk.

Plain-English summary

Customed, Inc. is recalling Tummy Tuck Pack- FJG, code 900-3114, due to a potential compromise in packaging integrity. The recall affects two lots (131210804 and 140111438) totaling 48 units. The product is an EO sterilized surgical convenient pack containing various instruments and supplies, including gowns, towels, needles, syringes, and surgical blades.

The recall was initiated because the compromised packaging could result in product contamination or a loss of sterility, which poses a risk of injury to patients. The affected products were distributed worldwide, including in the United States (nationwide, specifically Florida, Puerto Rico, and USVI) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.

Healthcare facilities and consumers who have these specific lots should stop using the products and contact Customed, Inc. for further instructions on return or disposal. The agency has classified this as a Class I recall, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.

The recalled product

Product: Tummy Tuck Pack- FJG, code 900-3114, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTIOM ST. HOLSTER (1) NEEDLE HYPODERMIC 22G X 1 Y2 (2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK (1) COUNTER NEEDLE & BLADE…
Manufacturer: Customed, Inc
Category: Medical Device — Surgical Packs
Hazard: contamination
loss-of-sterility

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

900-3114
2 lots: 131210804 140111438

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 233 recalled by Customed, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 233 products in this recall →

Same manufacturer · Customed, Inc

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Same hazard · contamination