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U.S. Department of Health and Human Services

Class 3 Device Recall Arrow EZIO Needle Set 45 mm 15 ga

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  Class 3 Device Recall Arrow EZIO Needle Set 45 mm 15 ga see related information
Date Initiated by Firm March 29, 2017
Date Posted April 04, 2017
Recall Status1 Terminated 3 on April 19, 2024
Recall Number Z-1829-2017
Recall Event ID 76872
510(K)Number K091140  
Product Classification Needle, hypodermic, single lumen - Product Code FMI
Product Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.
Code Information 4799431
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr
Research Triangle Park NC 27709-0186
For Additional Information Contact Elizabeth Norwood
866-246-6990 Ext. 68487
Manufacturer Reason
for Recall		 Some of the individual unit packaging (pouches) may be missing the lot number an expiration date.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action Consignees were notified of the recall by letter on March 29, 2017. The letter requested that they check their inventory and immediately discontinue use and quarantine any product and to inspect on hand for missing lot numbers and expiration date. The letter included a reply form to be returned to Teleflex. A separate letter was sent to distributors requesting a sub-recall.
Quantity in Commerce 4760 eaches
Distribution AL, AK, AZ AR, CA, CO, CT, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, Canada and Costa Rica
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 = FMI and Original Applicant = VIDACARE CORPORATION
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