PlainRecalls
FDA Devices Moderate Class II Ongoing

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) DE

Reported: September 18, 2024 Initiated: April 8, 2024 #Z-2999-2024

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

Reason for Recall

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.

Details

Distribution
Worldwide distribution.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by MEDLINE INDUSTRIES, LP - Northfield.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2024. Severity: Moderate. Recall number: Z-2999-2024.

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