Agency classClass IIOur severity:Severe FDA (Devices)·Z-1422-2016·Announced 2016-04-20

Customed Plastic Surgery Packs Recalled for Sterilization Validation Issues

Customed, Inc. is recalling 15 units of Plastic Surgery Packs (Catalog Number 9001402) distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 recall is classified as FDA Class II and involves a medical device where inadequate sterilization validation poses a significant risk of infection or injury, meeting the criteria for a Severe rating.

Plain-English summary

Customed, Inc. is recalling 15 units of Plastic Surgery Packs, Catalog Number 9001402. These medical device packs are used by medical staff to perform surgical procedures and patient care procedures, such as wound healing, suture removals, and wound irrigation. The affected lots are SL15175, SL15225, and SL15230.

The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile. The agency has classified this as a Class II recall.

The affected products were distributed only in Puerto Rico. Medical facilities and consumers who possess these specific lots should stop using them and contact the recalling firm for instructions on return or disposal.

The recalled product

Product: Catalog Number: 9001402 PLASTIC SURGERY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Manufacturer: Customed, Inc
Category: Medical Device — Surgical Packs
Hazard: infection
sterilization-failure
Affected units: 15

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 100 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 100 products in this recall →

Same manufacturer · Customed, Inc

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Same hazard · infection