Customed Ophthalmic Packs Recalled Due to Compromised Sterility
Customed, Inc. is recalling 96 Ophthalmic Packs (Catalog 900-1933) 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 explicitly states that the compromised sterility 'may result in patient infection.' Per the rubric, FDA Class I recalls with significant injury reports or risks (such as infection) are classified as Severe (Score 4).
Plain-English summary
Customed, Inc. is recalling 96 units of the Ophthalmic Pack, Catalog number 900-1933, under FDA recall number Z-0319-2015. These products are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected lot number is 140513465.
The recall was initiated because the products have 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. This risk may result in patient infection.
The products were distributed in the United States to Florida, New York, and Puerto Rico. Consumers and medical facilities should stop using these products and contact the recalling firm for further instructions.
The recalled product
- Product
- Ophtalmic Pack, Catalog number 900-1933. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Affected units
- 96
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 140513465
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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