Medical Device Recall: Bausch+Lomb Intravitreal Injection Kit Unvalidated Sterilization
Synergetics Inc is recalling Bausch+Lomb I-PACK Intravitreal Injection Kits because sterilization certificates could not be validated by the supplier. The FDA classified this as Class I.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I medical device recall. The rubric lists FDA Class I as a criterion for Critical (score 5), the highest severity classification.
Plain-English summary
Synergetics Inc is recalling BAUSCH+LOMB I-PACK Injection Kits with Drape (REF 18061) used for intravitreal injections into the eye.
The recall affects Lot Number P63044983R and has been distributed nationwide. The recall was initiated because sterilization certificates from the supplier could not be validated by Synergetics Inc, preventing confirmation of whether these devices are sterile.
Healthcare providers who have received kits from this lot should stop using them immediately and contact Synergetics Inc for instructions regarding return or destruction of the affected units.
The FDA classified this as a Class I recall, the agency's highest severity level, indicating that use of these devices could cause serious harm to patients.
The recalled product
- Product
- BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)
- Manufacturer
- Synergetics Inc
- Hazard
- sterilization-failure
- infection-risk
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 20841305107551
- Lot Number P63044983R
Distribution
Distributed nationwide across the United States.
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