Customed Lithotomy Pack Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 460 Lithotomy Packs due to compromised sterility and manufacturing deficiencies that may cause 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 deficiencies 'may result in patient infection,' which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk contamination scenarios that warrant a Severe classification.
Plain-English summary
Customed, Inc. is recalling 460 units of the Lithotomy Pack, catalog #900-2167. These products are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The recall is due to significant compromised sterility, which is not limited to potentially damaged packaging.
The recall is being issued because of serious deficiencies in manufacturing processes and uncontrolled and inadequate storage conditions. These issues increase the risk of contamination and may result in patient infection. The affected lot numbers are 140513126, 140513397, 140613659, 140714234, 140814768, and 140915245.
The products were distributed in the United States to Florida, New York, and Puerto Rico. Medical facilities and consumers who have these specific products should stop using them immediately and contact the manufacturer or their supplier for instructions on return or disposal.
The recalled product
- Product
- Lithotomy Pack, catalog #900-2167 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
- Affected units
- 460
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 140513126 140513397 140613659 140714234 140814768 140915245
Distribution
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.
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