—#208128

Product

Medline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025; 2) BABY CARE KIT UNIV, Pack Number DYKL1025H

FDA product code: CCX — Support, Patient Position
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: DYKL1025 , Lot Number 21JBA955 ; DYKL1025 , Lot Number 21LBX335 ; DYKL1025 , Lot Number 22BBW368 ; DYKL1025 , Lot Number 22FBT155 ; DYKL1025 , Lot Number 22IBA604 ; DYKL1025 , Lot Number 22JBJ323 ; DYKL1025 , Lot Number 23ABH574 ; DYKL1025 , Lot Number 23ABS213 ; DYKL1025 , Lot Number 23CBT397 ; DYKL1025 , Lot Number 23FBI255 ; DYKL1025 , Lot Number 23GBF800 ; DYKL1025 , Lot Number 23IBN598 ; DYKL1025H, Lot Number 21JBA955 ; DYKL1025H, Lot Number 21LBX335 ; DYKL1025H, Lot Number 22BBW368 ; DYKL1025H, Lot Number 22FBT155 ; DYKL1025H, Lot Number 22IBA604 ; DYKL1025H, Lot Number 22JBJ323 ; DYKL1025H, Lot Number 23ABH574 ; DYKL1025H, Lot Number 23ABS213 ; DYKL1025H, Lot Number 23CBT397 ; DYKL1025H, Lot Number 23FBI255 ; DYKL1025H, Lot Number 23GBF800 ; DYKL1025H, Lot Number 23IBN598

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 the 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

Timeline

Recall initiated: 2024-04-08
Posted by FDA: 2024-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208128. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.