BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for… recallZ-2253-2024 · Synergetics Inc · initiated Jun 12, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Synergetics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sterilization certificates could not be validated by the supplier
FDA root cause category: Under Investigation by firm
What the company is doing
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).
Recall details
- Recall number
- Z-2253-2024
- Status
- Open, Classified
- Initiated by the company
- Jun 12, 2024
- Posted by the FDA
- Jul 11, 2024
- Recalling firm
- Synergetics Inc
- Quantity
- 116 units
- Product code
- KDD
- Distribution
- US Nationwide
Product description
BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye)
Code information (models, lots, serial numbers)
UDI/DI 20841305107605, Lot Number P62764965R
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Synergetics 18069Synergetics USA, Inc. · Kit, Surgical Instrument, Disposable2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 94793).
- Z-2251-2024 · Open, ClassifiedBAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
- Z-2252-2024 · Open, ClassifiedBAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)
- Z-2254-2024 · Open, ClassifiedBAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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