—#208780

Product

Medline Convenience kits labeled as: 1) STEREOTACTIC BREAST BIOPSY TRA, Pack Number BT1095 ; 2) BREAST BIOPSY TRAY, Pack Number MNS5070; 3) BREAST BIOPSY TRAY-LF, Pack Number SPEC0058A; 4) BREAST BIOPSY TRAY, Pack Number DYNDH1142A; 5) BREAST BIOPSY TRAY, Pack Number SPEC0130B; 6) BIOPSY PACK SM, Pack Number DYNDH1093; 7) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A; 8) MAMMOGRAPHY BIOPSY TRAY, Pack Number DYNDH1304A; 9) LACERATION TRAY, Pack Number DYNDL1250C; 10) PULL D/C PACK, Pack Number DYNDA2080; 11) DIAGNOSTIC TRAY, Pack Number DYNDH1359; 12) OB DELIVERY SET, Pack Number MNS3355; 13) SUTURING SET, Pack Number SUT4020; 14) 22G FACET TRAY, Pack Number SPEC0265A; 15) ARTHROGRAM TRAY, Pack Number DYNDH1349; 16) BIOPSY TRAY W/O LIDOCAINE, Pack Number SPEC0196B; 17) ULTRASOUND BREAST BIOPSY, Pack Number DYNDH1496; 18) BREAST BIOPSY TRAY, Pack Number SPEC0130C; 19) DELIVERY ACCESSORY KIT, Pack Number MNS6496; 20) BREAST BIOPSY KIT, Pack Number DYNDH1706; 21) BIOPSY TRAY - LF, Pack Number DYNJTS0018A; 22) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 23) STEREOTACTIC BREAST BIOPSY TRAY, Pack Number DYNDH1755; 24) BREAST BIOPSY, Pack Number DYNDH1518A; 25) PORT INSERTION KIT, Pack Number MNS11590; 26) CORE BIOPSY TRAY, Pack Number SPEC0083B; 27) INFUSION CENTER BLOOD DRAW KIT, Pack Number DYNDH1798; 28) BREAST CENTER BIOPSY TRAY, Pack Number DYNDH1519; 29) AULTMAN HOSPITAL CHEST TUBE INSERTION TR, Pack Number CHT500; 30) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 31) ARTHROGRAM TRAY, Pack Number DYNDH1134; 32) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 33) BIOPSY TRAY, Pack Number DYNDH1269; 34) BIOPSY BASIC PACK, Pack Number DYNDH1588

FDA product code: PXP — Breast Biopsy / Localization Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: BT1095 , Lot Number 21HBO851 ; BT1095 , Lot Number 21JBA498 ; BT1095 , Lot Number 21KBS041 ; BT1095 , Lot Number 21LBI316 ; BT1095 , Lot Number 22IBE255 ; BT1095 , Lot Number 23CBL036 ; BT1095 , Lot Number 23DBE633 ; BT1095 , Lot Number 21ABU603 ; MNS5070, Lot Number 23LBC489; MNS5070, Lot Number 23HBL700; MNS5070, Lot Number 23EBJ365; SPEC0058A, Lot Number 2018110290; DYNDH1142A, Lot Number 2018120590; SPEC0130B, Lot Number 2018121290; SPEC0058A, Lot Number 2019012490; DYNDH1093, Lot Number 2019012490; SPEC0130B, Lot Number 2019020590; DYNDH1227A, Lot Number 2019020590; DYNDH1304A, Lot Number 2019040990; DYNDL1250C, Lot Number 2019040990; DYNDH1227A, Lot Number 2019040990; DYNDL1250C, Lot Number 2019040990; DYNDA2080, Lot Number 2019040990; SPEC0058A, Lot Number 2019060690; SPEC0130B, Lot Number 2019062890; SPEC0058A, Lot Number 2019070290; DYNDH1359, Lot Number 2019070290; MNS3355, Lot Number 2019062890; SPEC0130B, Lot Number 2019081590; SUT4020, Lot Number 2019081590; SPEC0265A, Lot Number 2019081590; DYNDH1349, Lot Number 2019081590; DYNDH1304A, Lot Number 2019112190; SPEC0196B, Lot Number 2019112190; DYNDH1349, Lot Number 2019112190; SPEC0130B, Lot Number 2019121190; DYNDH1496, Lot Number 2019122790; DYNDH1496, Lot Number 2020013190; DYNDH1496, Lot Number 2020120290; DYNDH1496, Lot Number 2021022590; SPEC0130C, Lot Number 2021051890; MNS6496, Lot Number 2021051890; SPEC0130C, Lot Number 2021071290; SPEC0130C, Lot Number 2021082490; SPEC0130C, Lot Number 2021091390; DYNDH1706, Lot Number 2022021550; SPEC0130C, Lot Number 2022020290; SPEC0130C, Lot Number 2022032990; DYNJTS0018A, Lot Number 2022032990; DYNDC2859A, Lot Number 2022032990; DYNDH1755, Lot Number 2022061050; DYNDH1518A, Lot Number 2022061050; SPEC0130C, Lot Number 2022081690; SPEC0130C, Lot Number 2022120290; MNS11590, Lot Number 2022120290; SPEC0083B, Lot Number 2022120290; DYNDH1798, Lot Number 2022120290; DYNDH1519, Lot Number 2022120690; CHT500, Lot Number 2022120690; DYNDH1519, Lot Number 2023020390; SPEC0130C, Lot Number 2023053190; DYNDH1519, Lot Number 2023081590; DYNDH1257, Lot Number 2018072450; DYNDH1257, Lot Number 2018080950; DYNDH1257, Lot Number 2018100350; DYNDH1257, Lot Number 2018113050; DYNDH1134, Lot Number 2018113050; DYNDH1319, Lot Number 2019011750; DYNDH1257, Lot Number 2019032150; DYNDH1319, Lot Number 2019073050; DYNDH1319, Lot Number 2019093050; DYNDH1319, Lot Number 2019103150; DYNDH1257, Lot Number 2020020350; DYNDH1257, Lot Number 2020033150; DYNDH1319, Lot Number 2020072050; DYNDH1269, Lot Number 2020072050; DYNDH1257, Lot Number 2020102950; DYNDH1319, Lot Number 2021021950; DYNDH1257, Lot Number 2021030350; DYNDH1257, Lot Number 2021120750; DYNDH1257, Lot Number 2022051350; DYNDH1319, Lot Number 2022052650; DYNDH1588, Lot Number 2022052650

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 #208780. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.