Recall record at a glance
| Official record | Z-3027-2024 |
|---|---|
| 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) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) CHEST TUBE INSERTION TRAY, Pack Number CHT1900; 3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 4) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 5) PORT TRAY , Pack Number DT19245; 6) BIOPSY KIT, Pack Number DYNDA1466A; 7) BIOPSY KIT, Pack Number DYNDA1466A; 8) CATH REMOVAL, Pack Number DYNDA1733B; 9) CATH REMOVAL, Pack Number DYNDA1814; 10) CATH REMOVAL, Pack Number DYNDA1814; 11) CATH REMOVAL, Pack Number DYNDA1814; 12) CATH REMOVAL, Pack Number DYNDA1814; 13) CATH REMOVAL, Pack Number DYNDA1814; 14) CATH REMOVAL, Pack Number DYNDA1814; 15) CATH REMOVAL, Pack Number DYNDA1814; 16) CATH REMOVAL, Pack Number DYNDA1814; 17) SHUNT TRAY, Pack Number DYNDA2725; 18) PORT ACCESS KIT, Pack Number DYNDC2945; 19) PORT ACCESS KIT, Pack Number DYNDC2945; 20) PORT ACCESS KIT, Pack Number DYNDC2945; 21) PORT ACCESS KIT, Pack Number DYNDC2945; 22) PORT ACCESS KIT, Pack Number DYNDC2945; 23) PORT ACCESS KIT, Pack Number DYNDC2945; 24) PORT ACCESS KIT, Pack Number DYNDC2945; 25) PORT ACCESS KIT, Pack Number DYNDC2945; 26) PORT ACCESS KIT, Pack Number DYNDC2945; 27) PORT ACCESS KIT, Pack Number DYNDC2945; 28) ARTHROGRAM TRAY, Pack Number DYNDH1113; 29) BIOPSY TRAY, Pack Number DYNDH1137C; 30) BIOPSY PACK, Pack Number DYNDH1248; 31) DIAGNOSTIC TRAY, Pack Number DYNDH1359; 32) MYELOGRAM TRAY, Pack Number DYNDH1531; 33) BIOPSY PACK, Pack Number DYNDL1462B; 34) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B; 35) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B; 36) PORT ACCESS TRAY, Pack Number EBSI1241; 37) PORT ACCESS TRAY, Pack Number EBSI1241; 38) PORT ACCESS TRAY, Pack Number EBSI1241; 39) PORT ACCESS TRAY, Pack Number EBSI1241; 40) PORT ACCESS TRAY, Pack Number EBSI1241; 41) PORT ACCESS TRAY, Pack Number EBSI1241; 42) PORT ACCESS TRAY, Pack Number EBSI1241; 43) PORT ACCESS TRAY, Pack Number EBSI1241; 44) PORT ACCESS TRAY, Pack Number EBSI1241; 45) PORT ACCESS TRAY, Pack Number EBSI1241; 46) PORT ACCESS TRAY, Pack Number EBSI1241; 47) PORT ACCESS TRAY, Pack Number EBSI1241; 48) PORT ACCESS TRAY, Pack Number EBSI1241; 49) PORT ACCESS TRAY, Pack Number EBSI1241; 50) PORT ACCESS TRAY, Pack Number EBSI1241; 51) PORT ACCESS TRAY, Pack Number EBSI1241; 52) PORT ACCESS TRAY, Pack Number EBSI1241; 53) PORT ACCESS TRAY, Pack Number EBSI1241; 54) DIALYSIS CHANGE KIT, Pack Number EBSI1453; 55) DIALYSIS CHANGE KIT, Pack Number EBSI1453; 56) DIALYSIS CHANGE KIT, Pack Number EBSI1453A; 57) DIALYSIS CHANGE KIT, Pack Number EBSI1453A; 58) OB DELIVERY TRAY, Pack Number MNS10875A; 59) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150; 60) OB DELIVERY SET, Pack Number MNS3355; 61) LUMBAR TRAY, Pack Number SPEC0177; 62) 22G FACET TRAY, Pack Number SPEC0265A; 63) FINE LACERATION KIT, Pack Number SUT19360; 64) LACERATION TRAY, Pack Number SUT20955; 65) LACERATION TRAY, Pack Number SUT3780; 66) LACERATION TRAY, Pack Number SUT3780; 67) SUTURING SET, Pack Number SUT4020
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.
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