Agency classClass IOur severity:Severe FDA (Devices)·Z-0317-2015·Announced 2014-12-10

Customed Arthroscopy Pack Recalled Due to Compromised Sterility

Customed, Inc. is recalling 12 Arthroscopy Packs (Catalog 900-1832) because compromised sterility and manufacturing deficiencies may result in patient infection.

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 that the compromised sterility 'may result in patient infection.' Per the rubric, FDA Class II recalls with hospitalization reports or significant injury reports are Severe. While no specific hospitalizations are listed, the explicit risk of infection from a sterile medical device places this in the Severe category (Score 4) as a significant health risk, distinct from theoretical risks (Score 3) or confirmed fatalities (Score 5).

Plain-English summary

Customed, Inc. is recalling 12 units of the Arthroscopy Pack, Catalog number 900-1832. These products are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The recall is limited to Lot number 140613947.

The recall was initiated because the products have compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination. These conditions may result in patient infection.

The affected products were distributed in the United States to Florida, New York, and Puerto Rico. Medical facilities that received these products should stop using them and contact the recalling firm for instructions.

The recalled product

Product: Arthroscopy Pack, Catalog number 900-1832. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Manufacturer: Customed, Inc
Category: Medical Device — Surgical Packs
Hazard: infection
contamination
Affected units: 12

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)

Lot numbers 140613947

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 179 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 179 products in this recall →

Same manufacturer · Customed, Inc

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Same hazard · infection