Customed C-Section Pack Recalled for Sterility Compromise and Contamination Risk
Customed, Inc. is recalling 122 C-Section Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a Class I medical device with a risk of patient infection due to compromised sterility, meeting the criteria for a Severe rating (FDA Class I or significant injury risk).
Plain-English summary
Customed, Inc. is recalling 122 units of the C-Section Pack, Catalog # 900-998. These sterile packs are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected units are associated with lot numbers 140513471, 140613852, and 140814555.
The recall was initiated due to 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. This contamination 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 lot numbers should stop using the products and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- C-Section Pack, Catalog # 900-998 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
- 122
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 140513471 140613852 140814555
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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