| Class 3 Device Recall Arrow EZIO Needle Set 45 mm 15 ga |  |
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
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = FMI
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