Customed Arthroscopy Packs Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 60 Arthroscopy Packs due to compromised sterility and manufacturing deficiencies that 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 deficiencies 'may result in patient infection,' which constitutes a significant injury risk. This 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 60 units of Arthroscopy Packs, Catalog # 900-902. These products are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected units were distributed to Florida, New York, and Puerto Rico.
The recall is being conducted because of significant compromised sterility, which is not limited to potentially damaged packaging. The source text indicates that serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions increase the risk of contamination. These conditions may result in patient infection.
The affected lot numbers are 140412917, 140513342, 140614032, and 140915195. Medical facilities and consumers should check their inventory for these specific lot numbers and stop using the affected products immediately.
The recalled product
- Product
- Arthroscopy Pack, Catalog # 900-902 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
- Affected units
- 60
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 140412917 140513342 140614032 140915195
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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