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U.S. Department of Health and Human Services

Class 2 Device Recall HEPARIN LOCK FLUSH SOLUTION

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 Class 2 Device Recall HEPARIN LOCK FLUSH SOLUTIONsee related information
Date Initiated by FirmMay 20, 2010
Date PostedJune 19, 2012
Recall Status1 Terminated 3 on June 20, 2012
Recall NumberZ-1824-2012
Recall Event ID 57878
Product Classification Heparin, vascular access flush - Product Code NZW
ProductHEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
Code Information Lot 406952 (Expiration Date 02/11)
Recalling Firm/
Manufacturer		 App Pharmaceuticals Llc
1501 E Woodfield Rd
Suite 300 East
Schaumburg IL 60173-6052
For Additional Information ContactMelanie Jackson
847-969-2700
Manufacturer Reason
for Recall		CGMP Deviations: Incomplete documentation associated with test results.
FDA Determined
Cause 2		Release of Material/Component prior to receiving test results
ActionAPP sent an URGENT DRUG RECALL LETTER and Response Form dated May 20, 2010, to all affected consignees. The consignees contacted were at the retail/ medical facilities/hospital IeveIs, including intermediate wholesale IeveIs. Direct distributor consignees were instructed to notify their customers immediately of this recall action, and direct them to discontinue distributing or dispensing the affected lots, plus return the affected products and lots to APP Pharmaceuticals, LLC in Bensenville, IL. Direct consignees with affected lots on hand were instructed to immediately discontinue distributing or dispensing the affected products and return them to APP Pharmaceuticals, LLC in Bensenville, IL 60106. Questions regarding the information on how to return product can be made to the firm's Quality Assurance Department at 1-866-716-2459. For questions regarding this recall call 847-969-2700.
Quantity in Commerce133,150 vials
DistributionNationwide Distribution and Puerto Rico
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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