FDA Medical Device Recalls (openFDA)
Synergetics Inc: BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
- Recall number
- Z-2254-2024
- Recalling firm
- Synergetics Inc
- Product
- BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
- Status
- Open, Classified
- Initiated
- 2024-06-12
- Posted
- 2024-07-11
- Terminated
- not on file
- Reason
- Sterilization certificates could not be validated by the supplier
- 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
- 35 units
- Distribution
- US Nationwide
- Lot, serial or model codes
- UDI/DI 20841305107612, Lot Number P62764970R
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDD
- Firm FEI
- 1000119053
- Firm city
- O Fallon
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28