Recall record at a glance
| Official record | Z-2999-2024 |
|---|---|
| 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) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J ; 2) ORAL SURGERY PACK , Pack Number DYNJ00354K ; 3) ORAL PACK-LF, Pack Number DYNJ0426048L ; 4) ORAL SURGERY PACK-LF, Pack Number DYNJ17477F ; 5) ORAL SURGERY PACK-LF, Pack Number DYNJ17477G ; 6) ORAL SURGERY PACK-LF, Pack Number DYNJ20491N ; 7) DENTAL PACK-LF, Pack Number DYNJ36724C ; 8) DENTAL PACK WRM-LF, Pack Number DYNJ41963C ; 9) DENTAL SURGICOUNT , Pack Number DYNJ45540D ; 10) DENTAL PACK , Pack Number DYNJ49021F ; 11) DENTAL PACK , Pack Number DYNJ49021G ; 12) EXTRACTION PACK , Pack Number DYNJ49329F ; 13) CSC-N ORAL SURGERY PACK , Pack Number DYNJ50873B ; 14) ORAL SURGERY PACK , Pack Number DYNJ52404D ; 15) ORAL SURGERY PACK , Pack Number DYNJ52404F ; 16) ORAL SURGERY PACK , Pack Number DYNJ52404G ; 17) ORAL SURGERY PK RFID, Pack Number DYNJ52404I ; 18) WCMC PEDS DENTAL PACK , Pack Number DYNJ56307A ; 19) MAJOR PERIO DENTAL KIT, Pack Number DYNJ58157A ; 20) MAJOR PERIO DENTAL KIT, Pack Number DYNJ58157B ; 21) SURGERY KIT , Pack Number DYNJ58158A ; 22) SURGERY KIT , Pack Number DYNJ58158B ; 23) ORL PACK, Pack Number DYNJ59073B ; 24) ORAL SURGERY, Pack Number DYNJ59941B ; 25) ORAL SURGERY, Pack Number DYNJ59941BH; 26) MINOR DENTAL PACK-LF, Pack Number DYNJ61727I ; 27) MINOR DENTAL PACK-LF, Pack Number DYNJ61727J ; 28) MINOR DENTAL PACK-LF, Pack Number DYNJ61727K ; 29) MINOR DENTAL PACK-LF, Pack Number DYNJ61727L ; 30) DENTAL PACK , Pack Number DYNJ62779D ; 31) DENTAL PACK , Pack Number DYNJ62779F ; 32) DENTAL PACK , Pack Number DYNJ62779G ; 33) ORAL SURGERY PACK , Pack Number DYNJ66450B ; 34) ORAL PACK NTX , Pack Number DYNJ68506C ; 35) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226A ; 36) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226B ; 37) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226C ; 38) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226D ; 39) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226DH; 40) DENTAL PACK , Pack Number DYNJ80375; 41) ORAL SURGERY PACK , Pack Number DYNJ80619; 42) ORAL SURGERY PACK , Pack Number DYNJ80619A ; 43) DEAN DENTAL PACK, Pack Number DYNJ80644; 44) DEAN DENTAL PACK, Pack Number DYNJ80644A ; 45) DENTAL MINOR PACK , Pack Number DYNJ83140; 46) DENTAL PACK , Pack Number DYNJ84533; 47) ORAL SURGERY PACK-LF, Pack Number DYNJ84849; 48) ORAL, Pack Number DYNJ902377G; 49) ORAL SURGERY PACK-LF, Pack Number DYNJ904595D; 50) NYGH-MAJOR DENTAL-LF, Pack Number DYNJ905540F; 51) NYGH-MINOR DENTAL-PLASTIC-LF, Pack Number DYNJ905551C; 52) NORTH DENTAL, Pack Number DYNJ906941B; 53) ORAL, Pack Number DYNJ908371 ; 54) ORAL, Pack Number DYNJ908371A; 55) ORAL, Pack Number DYNJ908371B; 56) ORAL, Pack Number DYNJ908371C; 57) DENTAL, Pack Number DYNJ909635 ; 58) DENTAL, Pack Number DYNJ909635A
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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