Customed Recalls Ophthalmic Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling ophthalmic surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of harm (contamination/loss of sterility) for a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Customed, Inc. is recalling specific ophthalmic surgical packs due to a potential compromise in packaging integrity. The recalled items include various surgical instruments, drapes, syringes, and needles packaged in EO sterilized surgical convenient packs. The company identified that the packaging may not be fully intact, which could affect the sterility of the contents.
The recall involves two lots of the product, totaling 60 units. The affected lots are identified by the codes 113099550 and 113109831, under product code 900-357. The distribution of these products was worldwide, including the United States (specifically Florida, Puerto Rico, and the US Virgin Islands) and several international locations such as Tortola, Trinidad, the Dominican Republic, Costa Rica, and Mexico.
The primary hazard associated with this recall is the risk of patient injury due to product contamination or the loss of the sterile condition of the surgical instruments. Users of these medical devices should check their inventory for the specific lot numbers listed and contact the manufacturer or their supplier for further instructions on how to handle the affected units.
The recalled product
- Product
- OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) OPHTALMIC DRAPE WITH POUCH LIF (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (10) COTTON TIP APPLICATOR 6" WOOD (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC 18G
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
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 (2)
- Product code 900-357
- 2 lots: 113099550 113109831
Distribution
Part of a larger recall action
This product is one of 233 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.
See all 233 products in this recall →Related recalls
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