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U.S. Department of Health and Human Services

Class 2 Device Recall injeTAK Adjustable Tip Needle

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  Class 2 Device Recall injeTAK Adjustable Tip Needle see related information
Date Initiated by Firm February 07, 2023
Date Posted April 28, 2023
Recall Status1 Open3, Classified
Recall Number Z-1478-2023
Recall Event ID 91831
510(K)Number K090830  
Product Classification endoscopic injection needle, gastroenterology-urology - Product Code FBK
Product injeTAK Adjustable Tip Needles
Needle Sheath diameter 6Fr with 35-50cm in length
Stainless-stell needle cannula is 25 gauge
Code Information Model DIS199, UDI-DI (GTIN): 00627825000017 Lots: D198592, D211823, D19C094, D211825, D197765, D215573, D19B105, D214446, D19C097, D213099, D19C742, D214448, D201666, D213385, D202622, D216690, D203779, D217602, D204597, D21A632, D198638, D21B406, D204100, D219650, D201620, D221275, D207081, D218636, D205443, D21C155, D205441, D221088, D205445, D222083, D207623, D223087, D20A091, D224083, D20C092, D224386, D208579, D225586, D20C094, D225589, D20A092, D227088, D20B085, D226108, D211094, D228087 Model DIS201, UDI-DI (GTIN): 00627825000024 Lots: D19B109, D214447, D199716, D211094, D19B106, D214449, D19C789, D215574, D19C788, D216689, D19C098, D219083, D19C743, D217081, D201667, D218089, D203778, D21B407, D202623, D21B081, D204598, D21A082, D205444, D221277, D205440, D21C156, D203783, D221089, D205442, D221276, D204101, D222084, D203780, D224084, D207624, D221087, D207082, D222082, D208580, D223088, D205446, D226109, D20B086, D224387, D20A093, D227089, D20C095, D228088, D20C093, D226107, D211824, D228197, D211095, D229088, D211826, D22A099, D213100, D22A719, D213386, D229086
Recalling Firm/
Manufacturer		 Labories Medical Technologies
180 International Dr
Portsmouth NH 03801-6837
Manufacturer Reason
for Recall		 The packaging may be damaged, compromising the sterile barrier.
FDA Determined
Cause 2		 Process control
Action A customer letter dated February 7, 2023 was issued to impacted consignees. The letter asks consignees to examine their inventory for affected product lots and to complete a response card to the recalling firm. Return of impacted product will be coordinated with Laborie Medical Technologies.
Quantity in Commerce 415,480 units
Distribution Worldwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FBK and Original Applicant = LABORIE MEDICAL TECHNOLOGIES, LTD.
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