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Class 2 Device Recall RAPIDFILL Syringe Strip |
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| Date Initiated by Firm |
April 16, 2014 |
| Date Posted |
May 14, 2014 |
| Recall Status1 |
Terminated 3 on March 23, 2015 |
| Recall Number |
Z-1620-2014 |
| Recall Event ID |
68030 |
| Product Classification |
Syringe, piston - Product Code FMF
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| Product |
RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200 RAPIDFILL Syringe Strip, White. H93890221 RAPIDFILL Syringe Strip, Yellow. H93890222 RAPIDFILL Syringe Strip, Orange. H93890223 RAPIDFILL Syringe Strip, Red. H93890225 RAPIDFILL Syringe Strip, Blue. H93890227 RAPIDFILL Syringe Strip, Salmon. H93890229 RAPIDFILL Syringe Strip, Violet. H93890231 RAPIDFILL Syringe Strip, Gray. H93890232 RAPIDFILL Syringe Strip, Green. Sterile 10 ml syringes with twist-off luer sealing tip caps banded together with label material. |
| Code Information |
Product Code: H93890200 Lots 787032 to 790790; Codes H93890221 Lots 789096 to 791247; Code H93890222 Lots 787761 to 790791; Code H93890223 Lots 786926 to 789793; Code H93890225 Lots 789794 to 790792; Code H93890227 Lots 789098 to 791246; Code H93890229 Lots 789637 to 790794; Code H93890231 Lots 788465 to 790795; Code H93890232 Lots 790796 to 791245 |
Recalling Firm/
Manufacturer |
Baxter Corporation Englewood
14445 Grasslands Dr
Englewood CO 80112-7062
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| For Additional Information Contact |
Center for One Baxter
800-422-9837
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Manufacturer Reason
for Recall |
Possible breach in sterile barrier for inner and outer bags of the
product.
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FDA Determined
Cause 2 |
Process control |
| Action |
Baxter sent an Urgent Product Recall letter dated April 30, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Baxter is requesting that you take the following actions:
1. Locate and remove all affected product from your facility (the product code and lot number can be found on the individual product package or shipping carton).
2. To return the affected product, receive credit and order replacement, please contact Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00am and 6:00pm Central Time. Please have your Baxter eight-digit ship-to account number ready when calling.
3. Complete the enclosed customer reply form, and return it to Baxter by either fax or scanned e-mail.
4. If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please conduct a recall with your end-user customers in accordance with your customary procedures.
If you have questions regarding the content of this communication, please call The Center for One Baxter at 1-800-422-9837 during the hours of
8:00am to 5:00 pm Central Time, Monday through Friday. |
| Quantity in Commerce |
774, 600 |
| Distribution |
Worldwide Distribution - US Distribution including the states of AL, AZ, CT, CA, FL, GA, OH, OR, IL, KS, MA, MI, MN, MO, NC, PA, HI, TN, VA, NV and WI and the country of Canada. |
| Total Product Life Cycle |
TPLC Device Report
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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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