Agency classClass IIOur severity:High FDA (Devices)·Z-1443-2016·Announced 2016-04-20

Customed Lithotomy Surgical Packs Recalled for Sterilization Validation Issues

Customed, Inc. is recalling 150 Lithotomy 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 is classified as FDA Class II and involves a risk-of-harm product (sterile surgical packs) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical or unreported harm risks.

Plain-English summary

Customed, Inc. is recalling 150 units of Catalog Number 9002167 Lithotomy Surgical Packs. 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 sterilization processes, as well as package integrity issues for products released for distribution as sterile.

The affected products were distributed only in Puerto Rico. The specific lots involved are SL15177, SL15180, SL15202, and SL15225, with manufacturing dates ranging from June 30, 2016, to August 31, 2016. The FDA has classified this recall as Class II, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare facilities and consumers who have these specific surgical packs should stop using them immediately and contact Customed, Inc. for further instructions on return or disposal. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product: Catalog Number: 9002167 LITHOTOMY 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-failure
Affected units: 150

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