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U.S. Department of Health and Human Services

Class 2 Device Recall Infusion Pump Basal/Bolus Infusor

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  Class 2 Device Recall Infusion Pump Basal/Bolus Infusor see related information
Date Initiated by Firm June 07, 2013
Date Posted June 27, 2013
Recall Status1 Terminated 3 on June 04, 2014
Recall Number Z-1606-2013
Recall Event ID 65365
510(K)Number K884505  
Product Classification Pump, infusion - Product Code FRN
Product Brand Name: Basal/Bolus Infusor.

Indicated for the intravenous administration of medications.
Code Information Product Codes: 2C1955KJP, 2C1976KJ  Lot Codes: 08K006 08M038 08N001 09C021 09E028 09F078 09H080 09J046 09M052 09N030 09N048 10A043 108023 10E054 10H055 10J031 10K050 10M085 10N026 09H033 10B028 10B081 10E004 10J106  Expiration Dates: 06/30/15, 12/31/14, 12/31/15, 06/30/14, 12/31/14
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Route 120 And Wilson Rd
Round Lake IL 60073-9799
For Additional Information Contact
847-270-5556
Manufacturer Reason
for Recall		 Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action An Urgent Product Recall notification was sent to all affected consignees on 06/13/2013. The letter states the affected products, problem description, hazard involved and actions to be taken by customer/user, with contact information. The letter was accompanied by a Customer Reply Form and a table of Affected Product List. The recall notification instructs customers to segregate affected product and contact Baxter for instructions for return of product.
Quantity in Commerce 3,255,096 total
Distribution Distributed Nationwide and in 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.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = BAXTER HEALTHCARE CORP.
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