Bausch+Lomb I-PACK Injection Kit Recalled for Unvalidated Sterilization
Synergetics Inc is recalling the Bausch+Lomb I-PACK Injection Kit nationwide because sterilization certificates could not be validated by the supplier. The unvalidated sterilization of this eye injection device poses a potential infection risk.
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: This is an FDA Class I recall. FDA Class I classification mandates a minimum severity score of 4. While no illnesses have been reported, unvalidated sterilization of invasive eye injection equipment creates a serious risk of infection.
Plain-English summary
Synergetics Inc is recalling the Bausch+Lomb I-PACK Injection Kit (REF 18060, Lot P62764979R) nationwide. This medical device is used for administering intravitreal injections—injections delivered directly into the eye. The recall affects 14 units.
The company initiated the recall because sterilization certificates provided by the supplier could not be validated. When sterilization cannot be confirmed for injection equipment, there is a risk of infection.
Patients who received intravitreal injections using this product and healthcare providers should be aware of this recall.
The recalled product
- Product
- BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
- Manufacturer
- Synergetics Inc
- Hazard
- infection-risk
- sterilization-failure
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 20841305107544
- Lot Number P62764979R
Distribution
Distributed nationwide across the United States.
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