Recall Z-2254-2024— Synergetics Inc
Class I · Ongoing
Class I FDA medical device recall by Synergetics Inc, initiated 2024-06-12. FDA's recall record names no specific 510(k) clearance for this event. Product: BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye). Reason: Sterilization certificates could not be validated by the supplier.
- Recalling firm
- Synergetics Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-06-12
- Firm location
- O Fallon, MO, United States
Product description
BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
Reason for recall
Sterilization certificates could not be validated by the supplier
Data sourced from openFDA. This site is unofficial and independent of the FDA.