Agency classClass IIOur severity:High FDA (Devices)·Z-1442-2016·Announced 2016-04-20

Customed Femoral Surgical Pack Recalled for Sterilization Validation Issues

Customed, Inc. is recalling 24 femoral surgical packs 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a sterile medical device with a defect in sterilization validation, creating a risk of infection or harm, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Customed, Inc. is recalling 24 units of the Femoral Surgical Pack (Catalog Number 9002164). These products are used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, and wound irrigation.

The recall was initiated because of inadequate validation and qualification of the sterilization processes and package integrity for products that were released for distribution as sterile. The affected lots are SL15169, SL15174, SL15184, SL15210, and SL15273, with expiration dates ranging from June 30, 2016, to September 30, 2016.

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

The recalled product

Product: Catalog Number: 9002164 FEMORAL SURGICAL 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-defect
Affected units: 24

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