—#209451

Product

Medline Convenience kits, labeled as: 1) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS983874F ; 2) HAND, Pack Number CDS984080F

FDA product code: OJH — Orthopedic Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: CDS983874F , Lot Number 19JDA152 ; CDS983874F , Lot Number 19KDC441 ; CDS983874F , Lot Number 20ADB656 ; CDS983874F , Lot Number 20BDC710 ; CDS983874F , Lot Number 20EDA493 ; CDS983874F , Lot Number 20FDB761 ; CDS983874F , Lot Number 20JDC993 ; CDS983874F , Lot Number 21ADB720 ; CDS983874F , Lot Number 21DDA797 ; CDS983874F , Lot Number 21FDB765 ; CDS983874F , Lot Number 21HDA924 ; CDS983874F , Lot Number 21KDA957 ; CDS983874F , Lot Number 22BDA224 ; CDS983874F , Lot Number 22DDB013 ; CDS983874F , Lot Number 22GDA535 ; CDS983874F , Lot Number 22HDC091 ; CDS983874F , Lot Number 22JDA459 ; CDS983874F , Lot Number 23ADB076 ; CDS983874F , Lot Number 23DDA408 ; CDS983874F , Lot Number 23FDB732 ; CDS983874F , Lot Number 23IDA600 ; CDS983874F , Lot Number 23LDA901 ; CDS983874F , Lot Number 24CDA648 ; CDS984080F, Lot Number 23FBF618; CDS984080F, Lot Number 23EBN989; CDS984080F, Lot Number 23BBR987; CDS984080F, Lot Number 23ABH436; CDS984080F, Lot Number 23ABF537; CDS984080F, Lot Number 22IBR063; CDS984080F, Lot Number 22HBJ841

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2024-04-08
Posted by FDA: 2024-09-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209451. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.