BAUSCH+LOMB I-PACK Injection Kit Recalled Due to Sterilization Validation Failure
FDA has recalled 116 units of BAUSCH+LOMB I-PACK Injection Kits because sterilization certificates could not be validated by the supplier, creating potential infection risk for patients receiving intravitreal eye injections.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a medical device. Per the rubric, FDA Class I recalls never score below 4. The hazard—inability to validate sterilization certificates for eye injection kits—creates potential infection risk, justifying a Severe classification.
Plain-English summary
Synergetics Inc is recalling 116 units of BAUSCH+LOMB I-PACK Injection Kit Custom (REF 18069) nationwide. This kit is used to administer intravitreal injections directly into the eye.
The recall is due to sterilization certificate validation failures by the supplier. Sterilization certificates could not be validated, meaning the affected kits may not meet required sterility standards. This creates a potential risk of infection for patients who receive injections using these kits.
The recalled lot is identified by Lot Number P62764965R and UDI/DI 20841305107605. Patients and healthcare providers who have received or used this product should contact their healthcare facility to determine if they received an affected unit.
For more information about this recall, contact Synergetics Inc or the FDA at the recall number Z-2253-2024.
The recalled product
- Product
- BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye)
- Manufacturer
- Synergetics Inc
- Affected units
- 116
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)
- UDI/DI 20841305107605
- Lot Number P62764965R
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Synergetics 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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