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U.S. Department of Health and Human Services

Class 2 Device Recall Medline

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 Class 2 Device Recall Medlinesee related information
Date Initiated by FirmSeptember 04, 2024
Date PostedOctober 23, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0175-2025
Recall Event ID 95415
Product Classification Gynecological laparoscopic kit - Product Code OHD
ProductMedline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; c) GYN ANCILARY PACK, REF DYNJ84509; d) GYN LITHOTOMY MINOR, REF DYNJ907707
Code Information a) REF DYNJ24362C, UDI/DI 40889942830054 (each), 10889942830053 (case), Lot Numbers: 24ABG207; b) REF DYNJ46774B, UDI/DI 40889942582748 (each), 10889942582747 (case), Lot Numbers: 23LBN531; c) REF DYNJ84509, UDI/DI 40195327372881 (each), 10195327372880 (case), Lot Numbers: 23LBL712; d) REF DYNJ907707, UDI/DI 40193489848978 (each), 10193489848977 (case), Lot Numbers: 24ABR224
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactKarin Johnson
866-359-1704
Manufacturer Reason
for Recall		It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
FDA Determined
Cause 2		Under Investigation by firm
ActionMedline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees.
Quantity in Commerce197 units
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Panama.
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.
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