Z-2254-2024Class I

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

Name: Z-2254-2024 BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal...
Creator: Synergetics Inc
Published: 2024-06-12
License: https://open.fda.gov/license/

Synergetics Inc / initiated 2024-06-12 / Open, Classified / root cause: sterility

FDA source

Synergetics Inc began a recall of BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye) on 2024-06-12. FDA classified it as Class I and gives the reason as "Sterilization certificates could not be validated by the supplier". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2254-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-06-12
Posted: 2024-07-11
Recalling firm: Synergetics Inc
Product: BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
Product code: KDD Kit, Surgical Instrument, Disposable
Reason for recall: Sterilization certificates could not be validated by the supplier
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: Bausch + Lomb issued an URGENT MEDICAL DEVICE VOLUNTARY RECALL notice to its consignees on 05/12/2024 via FedEx. The notice explained the issue, potential hazard, and requested the following: Required actions: 1. Immediately review your inventory and isolate the affected products to prevent unintended use. Please complete and submit the attached Recall Acknowledgement Form that has instructions regarding what to do with product on-hand. You will receive a credit for any returned or destroyed kits. 2. If you have further distributed or transferred the affected product, identify and notify those to whom you have distributed the product by forwarding this letter with the recall acknowledgement form. For questions or need any other support with our products, reach out to your Bausch + Lomb sales representative or our customer service team at (800-338-2020).
Quantity in commerce: 35 units
Distribution: US Nationwide
Product codes and lots: UDI/DI 20841305107612, Lot Number P62764970R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2254-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2251-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-11
Z-2252-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-11
Z-2253-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-11
Z-2254-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-11

Product code KDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)