Recall record at a glance
| Official record | Z-2998-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield |
| Report date | Sep 18, 2024 |
| Recall initiation date | Apr 8, 2024 |
| Location | Northfield, IL, United States |
Official product description
Medline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J; 2) BIOPSY PROCEDURE TRAY , Pack Number 00-400405C ; 3) BIOPSY DRAPE PACK , Pack Number 00-400762H ; 4) BIOPSY PROCEDURE PACK , Pack Number 00-400832N ; 5) BIOPSY PROCEDURE PACK , Pack Number 00-400832O ; 6) BIOPSY PROCEDURE PACK , Pack Number 00-400832P ; 7) BIOPSY PROCEDURE PACK , Pack Number 00-401261F ; 8) 6" FEMORAL ARTERIALLINE KIT, Pack Number ART245B; 9) BREAST BIOPSY KIT , Pack Number BT1085A; 10) BREAST BIOPSY PROCEDURE TRAY, Pack Number BX8375F; 11) BREAST/MINOR, Pack Number CDS980228X ; 12) BIOPSY CDS-LF , Pack Number CDS984667D ; 13) BIOPSY CDS-LF , Pack Number CDS984667F ; 14) BREAST-HERNIA-PORT CDS-LF , Pack Number CDS984853G ; 15) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 16) QSUM STEREO/US BIOPSY TRAY, Pack Number CT101; 17) PEDS VASCULAR ACCESS KIT, Pack Number CVI4960; 18) BIOPSY DEKALB PACK, Pack Number DM150A ; 19) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 20) COLONOSCOPY KIT , Pack Number DYKE1218 ; 21) BREAST BIOPSY KIT , Pack Number DYNDA1224B ; 22) TDC REMOVAL, Pack Number DYNDA1633A; 23) BREAST BIOPSY PACK, Pack Number DYNDA2378A ; 24) CUSTOM BIOPSY TRAY, Pack Number DYNDA2448; 25) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 26) BIOPSY/MYELOGRAM PACK, Pack Number DYNDA2655; 27) PICU LINE TRAY, Pack Number DYNDC1960A; 28) PORT ACCESS KIT, Pack Number DYNDC2945; 29) CT BIOPSY TRAY, Pack Number DYNDH1054; 30) PQ BIOPSY PACK (BPSJH), Pack Number DYNDH1108; 31) BIOPSY PACK , Pack Number DYNDH1110; 32) ARTHROGRAM TRAY, Pack Number DYNDH1113; 33) BIOPSY TRAY , Pack Number DYNDH1114; 34) BIOPSY TRAY, Pack Number DYNDH1129; 35) ARTHROGRAM TRAY, Pack Number DYNDH1134; 36) BIOPSY PACK , Pack Number DYNDH1137A ; 37) BREAST BIOPSY TRAY, Pack Number DYNDH1142C ; 38) BREAST BIOPSY TRAY, Pack Number DYNDH1152A ; 39) BIOPSY KIT, Pack Number DYNDH1156; 40) ULTRASOUND TRAY, Pack Number DYNDH1204; 41) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A; 42) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B; 43) CORE BIOPSY TRAY, Pack Number DYNDH1233; 44) BIOPSY PACK, Pack Number DYNDH1248; 45) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 46) BREAST BIOPSY TRAY, Pack Number DYNDH1266; 47) GENERAL BIOPSY TRAY , Pack Number DYNDH1268; 48) BIOPSY TRAY, Pack Number DYNDH1269; 49) OHS CT BIOPSY TRAY -LF, Pack Number DYNDH1270; 50) DB CT BIOPSY TRAY -LF , Pack Number DYNDH1270; 51) BIOPSY TRAY , Pack Number DYNDH1273; 52) BIOPSY PACK TAA COMPLIANT , Pack Number DYNDH1294; 53) BREAST BIOPSY TRAY, Pack Number DYNDH1296B ; 54) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 55) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 56) ISHAK IR DRAINAGE TRAY, Pack Number DYNDH1300; 57) BREAST BIOPSY TRAY, Pack Number DYNDH1302; 58) BREAST BIOPSY TRAY, Pack Number DYNDH1302H ; 59) BIOPSY TRAY, Pack Number DYNDH1314; 60) BIOPSY TRAY , Pack Number DYNDH1314A ; 61) MAMMOGRAPHY BREAST BIOPSY, Pack Number DYNDH1318; 62) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 63) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324; 64) BIOPSY TRAY, Pack Number DYNDH1328; 65) CT BIOPSY TRAY, Pack Number DYNDH1355A ; 66) BONE MARROW BIOPSY ASPIRATION , Pack Number DYNDH1376A ; 67) BREAST BIOPSY PACK, Pack Number DYNDH1425; 68) THYROID BIOPSY PACK , Pack Number DYNDH1430A ; 69) BONE MARROW BIOPSY KIT, Pack Number DYNDH1434; 70) SOFT TISSUE BIOPSY, Pack Number DYNDH1477; 71) ULTRASOUND BREAST BIOPSY, Pack Number DYNDH1496A ; 72) ULTRASOUND BREAST BIOPSY, Pack Number DYNDH1496AH; 73) BREAST BIOPSY , Pack Number DYNDH1518A ; 74) BIOPSY, Pack Number DYNDH1543; 75) BIOPSY PACK , Pack Number DYNDH1556; 76) BIOPSY PACK , Pack Number DYNDH1556D ; 77) IR BIOPSY TRAY, Pack Number DYNDH1569; 78) BIOPSY KIT, Pack Number DYNDH1570; 79) STEREOTACTIC BIOPSY , Pack Number DYNDH1572; 80) ULTRASOUND BIOPSY , Pack Number DYNDH1573A ; 81) BREAST BIOPSY , Pack Number DYNDH1575; 82) CT BIOP
Why the product 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.
Distribution information
Worldwide distribution.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.