Class 2 Device Recall Medline

• Date Initiated by Firm: April 08, 2024
• Date Posted: September 06, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2982-2024
• Recall Event ID: 94583
• Product Classification: Airway, oropharyngeal, anesthesiology - Product Code CAE
• Product: Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B ; 2) MER TRACH CDS , Pack Number CDS984376B ; 3) Flexible LMA Pack with Syringe and Lube, Size 1, Pack Number DYND300010P; 4) Flexible LMA Pack with Syringe and Lube, Size 1.5, Pack Number DYND300015P; 5) Flexible LMA Pack with Syringe and Lube, Size 2, Pack Number DYND300020P; 6) Flexible LMA Pack with Syringe and Lube, Size 2.5, Pack Number DYND300025P; 7) Flexible LMA Pack with Syringe and Lube, Size 3, Pack Number DYND300030P; 8) Flexible LMA Pack with Syringe and Lube, Size 4, Pack Number DYND300040P; 9) Flexible LMA Pack with Syringe and Lube, Size 5, Pack Number DYND300050P; 10) TRACHEOSTOMY TRAY , Pack Number DYNDJ1061A ; 11) TRACHEOSTOMY , Pack Number DYNJ45495F
• Code Information: CDS983142B , Lot Number 19DBQ261 ; CDS983142B , Lot Number 19FBD886 ; CDS983142B , Lot Number 19KBJ083 ; CDS984376B , Lot Number 21HBJ875 ; CDS984376B , Lot Number 21JBJ731 ; CDS984376B , Lot Number 22DBM097 ; CDS984376B , Lot Number 22EBK349 ; CDS984376B , Lot Number 19EBI656 ; CDS984376B , Lot Number 22HBS594 ; CDS984376B , Lot Number 19SBG293 ; CDS984376B , Lot Number 19IBF800 ; CDS984376B , Lot Number 22LBA281 ; CDS984376B , Lot Number 23ABC499 ; CDS984376B , Lot Number 23ABE884 ; CDS984376B , Lot Number 19VBG331 ; CDS984376B , Lot Number 23BBS463 ; CDS984376B , Lot Number 20DBF949 ; CDS984376B , Lot Number 20EBU288 ; CDS984376B , Lot Number 20HBP449 ; CDS984376B , Lot Number 20IBM472 ; CDS984376B , Lot Number 21ABF587 ; DYND300010P, Lot Number 59220061157; DYND300010P, Lot Number 59220122559; DYND300010P, Lot Number 59221040752; DYND300010P, Lot Number 59221071480; DYND300010P, Lot Number 59222030363; DYND300010P, Lot Number 59222051032; DYND300010P, Lot Number 59222061222; DYND300010P, Lot Number 59222040781; DYND300010P, Lot Number 59222040997; DYND300010P, Lot Number 59222071481; DYND300010P, Lot Number 59222071537; DYND300015P, Lot Number 59220061157; DYND300015P, Lot Number 59220122559; DYND300015P, Lot Number 59221040651; DYND300015P, Lot Number 59221050988; DYND300015P, Lot Number 59221091941; DYND300015P, Lot Number 59222051078; DYND300015P, Lot Number 59222051032; DYND300015P, Lot Number 59222081778; DYND300015P, Lot Number 59222081923; DYND300020P, Lot Number 59220061157; DYND300020P, Lot Number 59221030489; DYND300020P, Lot Number 59221061255; DYND300020P, Lot Number 59221102224; DYND300020P, Lot Number 59221112515; DYND300020P, Lot Number 59221122696; DYND300020P, Lot Number 59222040997; DYND300020P, Lot Number 59222051032; DYND300020P, Lot Number 59222061222; DYND300020P, Lot Number 59222071643; DYND300020P, Lot Number 59222081908; DYND300020P, Lot Number 59222040781; DYND300020P, Lot Number 59222071481; DYND300020P, Lot Number 59222081778; DYND300020P, Lot Number 59222081923; DYND300025P, Lot Number 59220061157; DYND300025P, Lot Number 59221030489; DYND300025P, Lot Number 59221061255; DYND300025P, Lot Number 59221071480; DYND300025P, Lot Number 59222051032; DYND300025P, Lot Number 59222061222; DYND300025P, Lot Number 59222081908; DYND300025P, Lot Number 59222081778; DYND300025P, Lot Number 59222081923; DYND300030P, Lot Number 59220061157; DYND300030P, Lot Number 59221020196; DYND300030P, Lot Number 59221030489; DYND300030P, Lot Number 59221040752; DYND300030P, Lot Number 59221081720; DYND300030P, Lot Number 59222010094; DYND300030P, Lot Number 59222010145; DYND300030P, Lot Number 59222030363; DYND300030P, Lot Number 59222040997; DYND300030P, Lot Number 59222040997; DYND300030P, Lot Number 59222040997; DYND300030P, Lot Number 59222051032; DYND300030P, Lot Number 59222061222; DYND300030P, Lot Number 59222071481; DYND300030P, Lot Number 59222071690; DYND300030P, Lot Number 59222081778; DYND300030P, Lot Number 59222081923; DYND300040P, Lot Number 59220061157; DYND300040P, Lot Number 59220122896; DYND300040P, Lot Number 59221030489; DYND300040P, Lot Number 59221050956; DYND300040P, Lot Number 59221061255; DYND300040P, Lot Number 59221061366; DYND300040P, Lot Number 59221071370; DYND300040P, Lot Number 59221071480; DYND300040P, Lot Number 59221071620; DYND300040P, Lot Number 59221050960; DYND300040P, Lot Number 59221061193; DYND300040P, Lot Number 59221081720; DYND300040P, Lot Number 59221102224; DYND300040P, Lot Number 59221112515; DYND300040P, Lot Number 59221112403; DYND300040P, Lot Number 59221122696; DYND300040P, Lot Number 59222030363; DYND300040P, Lot Number 59222051032; DYND300040P, Lot Number 59222051032; DYND300040P, Lot Number 59222051032; DYND300040P, Lot Number 59222051032; DYND300040P, Lot Number 59222061222; DYND300040P, Lot Number 59222040781; DYND300040P, Lot Number 59222040923; DYND300040P, Lot Number 59222071481; DYND300040P, Lot Number 59222071690; DYND300040P, Lot Number 59222081778; DYND300040P, Lot Number 59222081923; DYND300050P, Lot Number 59220061157; DYND300050P, Lot Number 59220122559; DYND300050P, Lot Number 59220122896; DYND300050P, Lot Number 59221030489; DYND300050P, Lot Number 59221061255; DYND300050P, Lot Number 59221071370; DYND300050P, Lot Number 59221050956; DYND300050P, Lot Number 59221050960; DYND300050P, Lot Number 59221112515; DYND300050P, Lot Number 59221112403; DYND300050P, Lot Number 59221122696; DYND300050P, Lot Number 59222040997; DYND300050P, Lot Number 59222040997; DYND300050P, Lot Number 59222040997; DYND300050P, Lot Number 59222040997; DYND300050P, Lot Number 59222051032; DYND300050P, Lot Number 59222061222; DYND300050P, Lot Number 59222040997; DYND300050P, Lot Number 59222071690; DYND300050P, Lot Number 59222081778; DYND300050P, Lot Number 59222081923; DYNDJ1061A , Lot Number 21IBM637 ; DYNDJ1061A , Lot Number 21KBR259 ; DYNDJ1061A , Lot Number 19BBL149 ; DYNDJ1061A , Lot Number 22HBA163 ; DYNDJ1061A , Lot Number 22LBS593 ; DYNDJ1061A , Lot Number 23BBR453 ; DYNDJ1061A , Lot Number 20ABI199 ; DYNDJ1061A , Lot Number 20ABQ477 ; DYNDJ1061A , Lot Number 20BBV927 ; DYNDJ1061A , Lot Number 20CBZ583 ; DYNDJ1061A , Lot Number 23HBA926 ; DYNDJ1061A , Lot Number 23IBU987 ; DYNDJ1061A , Lot Number 23KBF024 ; DYNDJ1061A , Lot Number 23KBI637 ; DYNDJ1061A , Lot Number 20IBH461 ; DYNDJ1061A , Lot Number 20IBH534 ; DYNDJ1061A , Lot Number 20JBU615 ; DYNJ45495F , Lot Number 21DME648
• 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.