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U.S. Department of Health and Human Services

Class 2 Device Recall DOUBLE FEMALE LUER LOCK ADAPTER SPECIAL ADAPTER TO CONVERT MALE FITTING TO A FEMALE LUER LOCK

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 Class 2 Device Recall DOUBLE FEMALE LUER LOCK ADAPTER SPECIAL ADAPTER TO CONVERT MALE FITTING TO A FEMALE LUER LOCKsee related information
Date Initiated by FirmOctober 16, 2018
Create DateNovember 05, 2019
Recall Status1 Terminated 3 on June 15, 2021
Recall NumberZ-0288-2020
Recall Event ID 83633
510(K)NumberK810637 
Product Classification Transducer, blood-pressure, extravascular - Product Code DRS
Product(1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and (2) Argon Medical Devices Double Male LL Adapter, Special Adapter to Convert a Female Fitting to Male LL, REF 040184000A, 25/box, Sterile, Rx. The firm name on the labels is Argon Medical Devices, Inc., Athens, TX.
Code Information (1) Double Female LL Adapter-special adapter to convert male fitting to a female luer lock - Lot numbers 11228606, 11227966, 11226655; and  (2) Double Male LL Adapter-special adapter to convert a female fitting to a male luer lock - Lot numbers 11227508, 11229885, 11230268, and 11231393.
FEI Number 1625425
Recalling Firm/
Manufacturer		 Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751-5002
For Additional Information ContactMs. Rebecca Ellis
903-675-9321
Manufacturer Reason
for Recall		The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
FDA Determined
Cause 2		Equipment maintenance
ActionThe recalling firm began issuing letters dated 10/16/2018 on 10/16/2018 via registered mail identifying the issue and the action to be taken by the customer.
Quantity in CommerceTotal number in recall for all products in dist: 49,130 units
DistributionDistribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DRS
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