SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66, 5675-76, 5918-39, 9208-66, 15190-16, 9065-25, 5918-39, 16066-15, 16066-15
FDA Recall Z-1370-2024 · Posted 2024-03-22
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Recalling FirmAlcon Research, LLC
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2024-02-21
Product Quantity886
Reason for Recall
Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgical procedure packs that were subsequently terminally sterilized, so after the packs are opened, syringes should be discarded at surgical case end, and not reshelved, because the use of non-sterile bulb irrigation syringes may increase infection risk.
Firm Action
On 2/21/24, correction notices were mailed to customers who were asked to do the following:
1) Review your inventory to determine if you have any affected product within your facility.
2) If you have any affected Custom Pak lots in inventory, please use the included stickers to label any affected product. If you have previously reshelved either of the affected Medline Bulb Irrigation Syringe lots, dispose them.
3) All components inside the Pak are intended to be used only for one specific surgical case and should be discarded at the end of the surgical case.
4) Forward the correction notice to all departments within your organization who may be in possession of affected product; and any other organization to which this product may have been transferred.
5) Complete and return the response form via email to [email protected]
Customers with questions or concerns can call the firm at 1-800-862-5266.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the states of OH, WV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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