Agency classClass IOur severity:Severe FDA (Devices)·Z-0250-2015·Announced 2014-12-10

Customed Skin Staple Removal Recalled Due to Compromised Sterility

Customed, Inc. is recalling Skin Staple Removal devices (Catalog 900-782) 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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk…"

Plain-English summary

Customed, Inc. is recalling 20,960 units of Skin Staple Removal devices, Catalog number 900-782. These medical devices are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.

The recall is due to compromised sterility, which is not limited to potentially damaged packaging. The FDA notes that serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions increase the risk of contamination, which may result in patient infection.

The affected products were distributed to Florida, New York, and Puerto Rico. The specific lot numbers involved are: 111112954, 111112965, 111123297, 111123444, 112010204, 112020511, 112030694, 112051651, 112052014, 112083064, 112093637, 112104287, 112114538, 112124884, 113025834, 113026068, 113036743, 113047031, 113057506, 113067936, 113067964, 140111127, 140312184, 140513161, 140613781, 140814822, and 1130688891. Healthcare facilities should stop using these devices and contact the manufacturer for instructions on return or disposal.

The recalled product

Product: Skin Staple Removal, Catalog number 900-782. 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 Instruments
Hazard: infection
contamination
Affected units: 20,960

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