Class 2 Device Recall Medline

• Date Initiated by Firm: April 08, 2024
• Date Posted: September 06, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3001-2024
• Recall Event ID: 94583
• Product Classification: Tray, surgical, ent - Product Code MMO
• Product: Medline Convenience kits labeled as: 1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ; 2) ZALE OTOLOGY CDS, Pack Number CDS983181D ; 3) BGMC GENERAL LAPAROSCOPY PK-LF, Pack Number DYNJ0664747A ; 4) NC3G MEDIASTINOSCOPY PACK-LF, Pack Number DYNJ0796243D ; 5) MEDIASTINOSCOPY PACK-LF , Pack Number DYNJ0796243F ; 6) RHINOPLASTY PACK, Pack Number DYNJ27333F ; 7) OSC OTOLOGY PACK-LF , Pack Number DYNJ37384C ; 8) OSC OTOLOGY PACK-LF , Pack Number DYNJ37384D ; 9) RHINO PACK, Pack Number DYNJ46504A ; 10) RHINO PACK, Pack Number DYNJ46504B ; 11) MEDIASTINOSCOPY TEGH-LF , Pack Number DYNJ46741B ; 12) PACEMAKER PACK, Pack Number DYNJ49787A ; 13) NASAL AND SINUS PACK, Pack Number DYNJ50425A ; 14) MSC SEPTO RHINO PACK-LF , Pack Number DYNJ51677A ; 15) MSC SEPTO RHINO PACK-LF , Pack Number DYNJ51677B ; 16) SEPTO RHINO PACK, Pack Number DYNJ53076C ; 17) PLASTIC ENT PACK - NTSC , Pack Number DYNJ54901A ; 18) RHINO/SEPTO/FESS PACK , Pack Number DYNJ55955B ; 19) RHINO/SEPTO/FESS PACK , Pack Number DYNJ55955C ; 20) MEDIASTINOSCOPY PACK, Pack Number DYNJ60872B ; 21) NOSE ESC, Pack Number DYNJ62371A ; 22) NASAL PACK, Pack Number DYNJ67789A ; 23) LOU MAJOR ENT , Pack Number DYNJ901851D; 24) LOU MINOR ENT , Pack Number DYNJ901852C; 25) RHYZOTOMY , Pack Number DYNJ902288G; 26) CHS NASAL AND SINUS PACK, Pack Number DYNJCH501
• Code Information: CDS983173G , Lot Number 21FBQ527 ; CDS983173G , Lot Number 21HBF657 ; CDS983173G , Lot Number 21IBE910 ; CDS983173G , Lot Number 21IBM809 ; CDS983173G , Lot Number 21JBJ185 ; CDS983173G , Lot Number 21KBM498 ; CDS983173G , Lot Number 22ABF773 ; CDS983173G , Lot Number 22BBH011 ; CDS983173G , Lot Number 19ABX210 ; CDS983173G , Lot Number 22OBM500 ; CDS983173G , Lot Number 22EBQ566 ; CDS983173G , Lot Number 19GBS147 ; CDS983173G , Lot Number 19IBG146 ; CDS983173G , Lot Number 19IBJ785 ; CDS983173G , Lot Number 19KBA219 ; CDS983173G , Lot Number 19KBA926 ; CDS983173G , Lot Number 20BBA113 ; CDS983173G , Lot Number 20CBP609 ; CDS983173G , Lot Number 20DBU576 ; CDS983173G , Lot Number 20HBQ718 ; CDS983173G , Lot Number 20KBY137 ; CDS983173G , Lot Number 20LBL243 ; CDS983173G , Lot Number 21BBO662 ; CDS983173G , Lot Number 21EBC912 ; CDS983181D , Lot Number 21FBP606 ; CDS983181D , Lot Number 21FBP608 ; CDS983181D , Lot Number 21GBM695 ; CDS983181D , Lot Number 21IBW768 ; 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• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Karin Johnson; 886-359-1704
• Manufacturer Reason for Recall: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
• FDA Determined Cause: Under Investigation by firm
• Action: Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request these syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.
• 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.