Medical device recalls High risk

Synergetics Inc recalls BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)

Recall date
June 12, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2254-2024
FDA classification
Class I
Brand / firm
Synergetics Inc
Sold / distributed
US Nationwide

Why it was recalled

Sterilization certificates could not be validated by the supplier

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)

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