BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)
Summary
The FDA issued a Class I for BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration by Synergetics Inc. Reason: Sterilization certificates could not be validated by the supplier.
Details
Source
Device Recall
External ID
Z-2252-2024
Action Date
2024-07-17
Status
Ongoing
Category
device
Product Description
BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)
Lot/Code Info: UDI/DI 20841305107551, Lot Number P63044983R
Quantity Affected: 2 units
Reason for Recall
Sterilization certificates could not be validated by the supplier
Distribution
US Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-12
Company
O Fallon, MO
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 188 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Synergetics Inc has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Synergetics Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Synergetics Inc have FDA actions?
Synergetics Inc has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2252-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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