Customed OB Packs Recalled Due to Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 120 OB Packs used for wound care 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 contamination '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 medical device defects, warranting a score of 4.
Plain-English summary
Customed, Inc. is recalling 120 units of OB Packs, Catalog number 900-1717. These medical supplies are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is being conducted because of 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, which may result in patient infection.
The affected products were distributed in the United States to Florida, New York, and Puerto Rico. The specific lot numbers involved are 140513109, 140613626, 140714200, and 140814737. Medical facilities should stop using these products and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- OB Pack, Catalog number 900-1717. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 120
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 140513109 140613626 140714200 140814737
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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