3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
FDA Recall Z-0055-2013 · Posted 2012-10-11
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Recalling FirmICU Medical, Inc.
Recall StatusTerminated
Product CodeDQO
Date Initiated2012-09-28
Date Terminated2013-02-19
Product Quantity60
Reason for Recall
ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip
chamber may have been included on a 20 drop macro drip set.
Firm Action
ICU Medical sent an "URGENT:MEDICAL DEVICE RECALL" letter dated September 28, 2012 to its customer. The letter identified the product, problem, and actions to be taken by the customer. The customer has been instructed to inspect their inventory for the specific lot numbers, examine for the presence of a metal cannula, and certify destruction of any affected devices. The customer letter included a Verification Form to be completed and returned. Contact ICU
Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: [email protected]" for questions regarding this notice.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Nationwide distribution: Virginia only.
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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