Recall record at a glance
| Official record | Z-2767-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield |
| Report date | Sep 4, 2024 |
| Recall initiation date | Apr 8, 2024 |
| Location | Northfield, IL, United States |
Official product description
Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number ART1170; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) ARTHROGRAPH TRAY, Pack Number MNS12670A; 5) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 6) BIOPSY TRAY, Pack Number BT1060; 7) BIOPSY TRAY, Pack Number BT1015; 8) BIOPSY TRAY, Pack Number DYNDH1137C; 9) BIOPSY TRAY-LF, Pack Number SPEC4380; 10) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214; 11) BREAST BIOPSY TRAY, Pack Number SPEC0130C; 12) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09; 13) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 14) CIRCUMCISION TRAY, Pack Number CIT7050C; 15) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162; 16) CVC INSERT BUNDLE 16CM, Pack Number ECVC7860; 17) ER CHEST TUBE TRAY, Pack Number CHT1570A; 18) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150; 19) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 20) LOCAL INFILTRATION TRAY, Pack Number DYNDH1406; 21) LUMBAR PUNCTURE TRAY, Pack Number PT215; 22) LUMBAR TRAY, Pack Number SPEC0197B; 23) NICU PICC KIT, Pack Number CVI4575; 24) OB DELIVERY TRAY, Pack Number MNS10875A; 25) ON/OFF KIT, Pack Number DT8525; 26) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320; 27) PERIPHERAL BLOOD CULTURE KIT (1 SET), Pack Number DYNDH1910; 28) PERITONSILLAR ABSCESS TRAY, Pack Number MNS3560; 29) PORT ACCESS KIT, Pack Number DYNDC2945; 30) PORT ACCESS TRAY, Pack Number EBSI1241; 31) PORT INSERTION KIT, Pack Number MNS11590; 32) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 33) STEREOTACTIC TRAY, Pack Number MNS5785; 34) SUTURING SET, Pack Number SUT4020; 35) U.A.C. TRAY, Pack Number UVT125; 36) ULTRASOUND TRAY, Pack Number MNS5460; 37) UMBILICAL VES CATH INSERT TRAY, Pack Number UVT1080; 38) UMBILICAL VESSEL TRAY, Pack Number UVT1100A; 39) VAGINAL DELIVERY TRAY, Pack Number MNS11020A
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
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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