—#208789

Product

Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON SUPPLEMENTAL PACK , Pack Number DYNDA3019; 3) L & D PACK-LF , Pack Number DYNJ16121O ; 4) FAMILY PLANNING PACK, Pack Number DYNJ59783C ; 5) NEW LIFE PACK , Pack Number DYNJ69208A ; 6) NEW LIFE PACK , Pack Number DYNJ69208B ; 7) RADIOLOGY PACK, Pack Number DYNJ69603; 8)AMBULATORY MINI PACK, Pack Number DYNJ82579; 9) NURSING SKILLS, Pack Number EDUC1023

FDA product code: NSB — Patient Personal Hygiene Kit
Device class: Class 1
Medical specialty: Dental
Affected lot / code info: DYKA1225B, Lot Number 21GMC515 ; DYNDA3019, Lot Number 23BBO847 ; DYNDA3019, Lot Number 23GBI102 ; DYNDA3019, Lot Number 23HBO766 ; DYNJ16121O , Lot Number 23BBR366 ; DYNJ16121O , Lot Number 23DBR520 ; DYNJ16121O , Lot Number 23FBU745 ; DYNJ16121O , Lot Number 23GBV975 ; DYNJ16121O , Lot Number 23IBR246 ; DYNJ16121O , Lot Number 23LBR806 ; DYNJ16121O , Lot Number 24ABR196 ; DYNJ59783C , Lot Number 21KMF298 ; DYNJ59783C , Lot Number 23FMC164 ; DYNJ69208A , Lot Number 22KBV360 ; DYNJ69208A , Lot Number 23FBE076 ; DYNJ69208B , Lot Number 23IBN578 ; DYNJ69208B , Lot Number 23KBR836 ; DYNJ69603, Lot Number 21HMG219 ; DYNJ69603, Lot Number 21JMI295 ; DYNJ69603, Lot Number 22BMB206 ; DYNJ69603, Lot Number 22GMB031 ; DYNJ69603, Lot Number 22HMA445 ; DYNJ69603, Lot Number 22HMF745 ; DYNJ69603, Lot Number 22IME788 ; DYNJ69603, Lot Number 22JME874 ; DYNJ69603, Lot Number 23EMD691 ; DYNJ69603, Lot Number 23FMA290 ; DYNJ69603, Lot Number 23FMH511 ; DYNJ82579, Lot Number 23LBO804; DYNJ82579, Lot Number 23KBO218; DYNJ82579, Lot Number 23IBM199; DYNJ82579, Lot Number 23GBQ788; DYNJ82579, Lot Number 23EBT027; DYNJ82579, Lot Number 23EBC375; DYNJ82579, Lot Number 23CBP897; DYNJ82579, Lot Number 23BBG331; DYNJ82579, Lot Number 22LBH343; DYNJ82579, Lot Number 22HBQ045; EDUC1023 , Lot Number 22HDA683 ; EDUC1023 , Lot Number 22HDA854

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 #208789. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.