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U.S. Department of Health and Human Services

Class 2 Device Recall HenkeJect

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 Class 2 Device Recall HenkeJectsee related information
Date Initiated by FirmJuly 27, 2023
Date PostedSeptember 27, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2642-2023
Recall Event ID 92836
510(K)NumberK821537 
Product Classification Syringe, piston - Product Code FMF
ProductHenke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous and intraarterial injection of liquids or diluted drugs in combination with an adequate medical device or for withdrawal of fluids from the body. Ref: 4100.000V0
Code Information UDI-DI: 04035873062004 and 04035873061991 Lot: 22M28C8 Lot: 23A09C8
Recalling Firm/
Manufacturer		 Wolf, Henke Sass, Gmbh
Kronenstrasse 16
Tuttlingen Germany
Manufacturer Reason
for Recall		Sterile barrier might be damaged compromising the sterility of the device.
FDA Determined
Cause 2		Under Investigation by firm
ActionHenke-Sass, Wolf GmbH notified the US Distributor on 7/24/24 via email and telecon. US Distributor notified their consignees (Distributors)via phone/ email on July 27, 2023. Letter states reason for recall, health risk and action to take: 1. Immediately remove any of these items with these lot numbers from active inventory. 2. Whether you do or do not have any of the items remaining in inventory, please complete the attached response form and return to atinfo@air-tite.com. 3. If you have inventory remaining, you will receive instructions and a return label once we have received your completed form. 4. If you have sent this product to another customer, forward this information, or collect the information and submit a response on their behalf. 5. If you have imported or distributed these products in Canada, please note that Health Canada has been notified and you may have specific additional obligations. If you have any questions or concerns, please contact us, atinfo@air-tite.com, (800) 231-7762.
Quantity in Commerce216,000
DistributionWorldwide distribution - US Nationwide and the country of Canada.
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 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) Database510(K)s with Product Code = FMF
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