Customed Recalls Cataract Packs Due to Sterility Compromise
Customed, Inc. is recalling 1,140 cataract 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 source text explicitly states that the deficiencies 'may result in patient infection,' which constitutes a significant injury risk. Per the rubric, significant injury reports or risks warrant a score of 4 (Severe).
Plain-English summary
Customed, Inc. is recalling 1,140 units of the Cataract Pack, Catalog # 900-944. These medical device packs 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 significant compromised sterility, which is not limited to potentially damaged packaging. The source text notes that serious deficiencies in manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and 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 140513353, 140613850, 140714553, 140814881, and 140815097. Healthcare facilities should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- Cataract Pack, Catalog # 900-944 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
- 1,140
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 140513353 140613850 140714553 140814881 140815097
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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