Agency classClass IIOur severity:High FDA (Devices)·Z-2613-2015·Announced 2015-09-09

Customed HIP Ortho. Pack Recalled for Sterilization Validation Issues

Customed, Inc. is recalling HIP Ortho. Packs due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.

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 medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Customed, Inc. is recalling HIP Ortho. Packs (Code: 9001835, Lot: 150418324, Exp. 5/31/16) because of inadequate validation and qualification of sterilization processes and package integrity for products released for distribution as sterile. These packs are used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, and wound irrigation.

The recall is limited to products distributed only in Puerto Rico. The FDA has classified this as a Class II recall, indicating that 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.

Consumers and healthcare facilities should stop using the affected lots and contact the recalling firm for instructions on return or disposal.

The recalled product

Product: HIP ORTHO. PACK 3/CS 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: sterilization-failure
package-integrity
Affected units: 3

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 (1)

Code:9001835 Lots: 150418324 exp. 5/31/16

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 170 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 170 products in this recall →

Same manufacturer · Customed, Inc

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Same hazard · sterilization failure