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.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Affected units
- 2
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.
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.
See all 4 products in this recall →Related recalls
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