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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 SOLUTION see related information
Date Initiated by Firm May 20, 2010
Date Posted June 19, 2012
Recall Status1 Terminated 3 on June 20, 2012
Recall Number Z-1825-2012
Recall Event ID 57878
Product Classification Heparin, vascular access flush - Product Code NZW
Product HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, NDC 63323-545-05, Product Code 504505; Rx only

To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
Code Information Product Code 504501 (1 mL): Lot 406912 (Expiration Date 01/11) and Lot 408072 (Expiration Date 09/11); Product Code 504505 (5 mL): Lot 406914 (Expiration Date 01/12)
Recalling Firm/
Manufacturer		 App Pharmaceuticals Llc
1501 E Woodfield Rd
Suite 300 East
Schaumburg IL 60173-6052
For Additional Information Contact Melanie 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
Action APP 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 Commerce Product Code 504501 (1 mL): 454,275 vials; Product Code 504505 (5 mL): 119,325 vials
Distribution Nationwide Distribution and Puerto Rico
Total Product Life Cycle TPLC 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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