—#208611

Product

Medline Convenience kits labeled as: TONSIL & ADENOID PACK, Pack Number DYNJ43427C

FDA product code: KCB — Tube, Tonsil Suction
Device class: Class 1
Medical specialty: Ear, Nose, Throat
Affected lot / code info: DYNJ43427C , Lot Number 21HBA933 ; DYNJ43427C , Lot Number 22ABL557 ; DYNJ43427C , Lot Number 22BBL591 ; DYNJ43427C , Lot Number 19ABE939 ; DYNJ43427C , Lot Number 19ABM274 ; DYNJ43427C , Lot Number 19ABT846 ; DYNJ43427C , Lot Number 22DBL373 ; DYNJ43427C , Lot Number 22FBV273 ; DYNJ43427C , Lot Number 22GBE783 ; DYNJ43427C , Lot Number 22HBY245 ; DYNJ43427C , Lot Number 22IBS212 ; DYNJ43427C , Lot Number 19IBD112 ; DYNJ43427C , Lot Number 22KBT930 ; DYNJ43427C , Lot Number 22KBV623 ; DYNJ43427C , Lot Number 19JBZ344 ; DYNJ43427C , Lot Number 23ABM258 ; DYNJ43427C , Lot Number 23CBQ295 ; DYNJ43427C , Lot Number 23DBQ887 ; DYNJ43427C , Lot Number 23EBQ116 ; DYNJ43427C , Lot Number 20BBH601 ; DYNJ43427C , Lot Number 23GBI661 ; DYNJ43427C , Lot Number 20DBE542 ; DYNJ43427C , Lot Number 23HBQ003 ; DYNJ43427C , Lot Number 20EBM157 ; DYNJ43427C , Lot Number 23JBX153 ; DYNJ43427C , Lot Number 20GBU737 ; DYNJ43427C , Lot Number 20HBR283 ; DYNJ43427C , Lot Number 23LBR867 ; DYNJ43427C , Lot Number 20IBB669 ; DYNJ43427C , Lot Number 20IBK144

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 #208611. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.