Customed Femoral Pack Recalled Due to Sterility Compromise and Contamination Risk
Customed, Inc. is recalling 92 units of Femoral Packs (catalog #900-2164) 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 explicitly states that the deficiencies 'may result in patient infection,' which constitutes a risk of significant injury. Per the rubric, risk-of-harm products where injury has not yet been reported but the potential for significant harm exists aligns with a score of 4 (Severe), as it exceeds the threshold for theoretical risk (Score 3) due to the explicit mention of infection resulting from compromised sterility.
Plain-English summary
Customed, Inc. is recalling 92 units of the Femoral Pack, catalog #900-2164. These medical packs are used by staff for 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 due to significant compromised sterility, which is not limited to potentially damaged packaging. 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 140412645, 140513125, 140613658, 140714233, and 140714335. Healthcare facilities and consumers should stop using these products and contact the recalling firm for further instructions.
The recalled product
- Product
- Femoral Pack, catalog #900-2164 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
- 92
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 140412645 140513125 140613658 140714233 140714335
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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