Recall record at a glance
| Official record | Z-2743-2024 |
|---|---|
| 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
Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q; 2) OPEN HEART CDS, Pack Number CDS982411N; 3) OPEN HEART, Pack Number CDS983348AA; 4) OPEN HEART, Pack Number CDS983348X; 5) OPEN HEART, Pack Number CDS983348Y; 6) HMT CV SET UP CDS, Pack Number CDS984206R; 7) OPEN HEART PEDS PACK, Pack Number CMPJ01037P; 8) OPEN HEART A&B PACK, Pack Number CMPJ02162I; 9) HMT SMALL TABLE PACK, Pack Number CMPJ03510J; 10) MAJOR VASCULAR PACK, Pack Number CMPJ06631C; 11) VASCULAR PACK, Pack Number CMPJ08949F; 12) BOISE HEART PACK-LF, Pack Number CMPJ09225F; 13) VASCULAR PACK, Pack Number CMPJ09236D; 14) VASCULAR/OR ANGIO PACK, Pack Number CMPJ09236F; 15) CAROTID ENDARTERECTOMY PACK, Pack Number CMPJ09400C; 16) CAROTID PACK, Pack Number CMPJ10797B; 17) CAROTID ENDARTERECTOMY, Pack Number CMPJ10985A; 18) CAROTID ENDARTERECTOMY, Pack Number CMPJ10985B; 19) VASCULAR PACK, Pack Number CMPJ13632; 20) OPEN HEART DRAPE PACK-LF, Pack Number DYNJ0382048M; 21) CABG PACK-LF, Pack Number DYNJ0824648K; 22) HEART PEDIATRIC PACK-LF, Pack Number DYNJ16541R; 23) ADULT CARDIO TRAY, Pack Number DYNJ35495G; 24) ADULT CARDIO TRAY, Pack Number DYNJ35495G; 25) PEDIATRIC CARDIO CATH PACK, Pack Number DYNJ35578G; 26) MAJOR VASCULAR PACK, Pack Number DYNJ38318F; 27) MAJOR VASCULAR PACK, Pack Number DYNJ38318G; 28) EP PACER PACK, Pack Number DYNJ38863N; 29) EP PACER PACK, Pack Number DYNJ38863O; 30) PERFUSION SYRINGE, Pack Number DYNJ39223C; 31) VASCULAR PACK, Pack Number DYNJ39525; 32) VASCULAR ADD ON PACK, Pack Number DYNJ44420C; 33) SHUNT ENDARTERECTOMY, Pack Number DYNJ44565D; 34) VASCULAR ACCESS PACK, Pack Number DYNJ56510A; 35) HEART VALVE PACK, Pack Number DYNJ58365J; 36) RIGHT HEART PACK MOSES, Pack Number DYNJ58873A; 37) GENERAL VASCULAR PACK, Pack Number DYNJ60177A; 38) PK CUST PERIPHERAL VASCUL, Pack Number DYNJ60904A; 39) PK CUST PERIPHERAL VASCUL, Pack Number DYNJ60904B; 40) PK CUST PERIPHERAL VASCUL, Pack Number DYNJ60904C; 41) PK, VASCULAR-MAJOR, Pack Number DYNJ61603A; 42) VASCULAR PACK, Pack Number DYNJ63182A; 43) VASCULAR SHARED, Pack Number DYNJ64801B; 44) VASCULAR PACK, Pack Number DYNJ65160; 45) VASCULAR DSC, Pack Number DYNJ69172B; 46) OPEN HEART PACK, Pack Number DYNJ83695; 47) WMC HYBRID OR, Pack Number DYNJ904036J; 48) VASCULAR, Pack Number DYNJ904845G; 49) BOISE HEART, Pack Number DYNJ905070I; 50) VASCULAR/OR ANGIO, Pack Number DYNJ905079F; 51) VASCULAR PACK, Pack Number DYNJ905226D; 52) CAROTID, Pack Number DYNJ906561F; 53) CAROTID ENDARTERECTOMY, Pack Number DYNJ906744A; 54) CAROTID ENDARTERECTOMY, Pack Number DYNJ906744B; 55) UNIVERSITY VASCULAR, Pack Number DYNJ907201B; 56) KIT OPEN HEART, Pack Number DYNJ908603B; 57) VASCULAR PACK, Pack Number DYNJ909374; 58) ISLET CELL UNIV OF IL, Pack Number DYNJ909768; 59) ADULT CORONARY PACK, Pack Number DYNJV0275J; 60) ADULT CORONARY PACK, Pack Number DYNJV0275K; 61) ADULT CORONARY PACK, Pack Number DYNJV0275M; 62) ADULT CORONARY PACK, Pack Number DYNJV0275N
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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