Customed Strabismus And Plastic Pack Recalled for Sterility Compromise
Customed, Inc. is recalling 120 Strabismus And Plastic Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of 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 justify a score of 4 (Severe).
Plain-English summary
Customed, Inc. is recalling 120 units of the Strabismus And Plastic Pack, Catalog # 900-946. These packs are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is due to significant 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 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 140513384, 140613786, 140714318, 140814828, and 140915190. Medical facilities should stop using these products and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Strabismus And Plastic Pack, Catalog # 900-946 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
- 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 140513384 140613786 140714318 140814828 140915190
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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