Customed O.B. Pack Recall Due to Sterility Compromise
Customed, Inc. is recalling 420 O.B. Packs (Catalog 900-645) 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 agency classification is FDA Class I, which mandates a minimum score of 4 per the rubric. The hazard involves compromised sterility and risk of patient infection, which aligns with the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Customed, Inc. is recalling 420 units of the O.B. Pack, Catalog number 900-645. These medical packs are used by staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The recall covers specific lot numbers 140513351, 140613843, 140814682, and 140814880.
The recall was initiated due to significant compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions have increased the risk of contamination. These conditions may result in patient infection.
The affected 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 and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- O.B. Pack, Catalog number 900-645. 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
- 420
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 140513351 140613843 140814682 140814880
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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