PlainRecalls
FDA Devices Moderate Class II Ongoing

Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY, Pack Number AM110A ; 3) HIP , Pack Number BM200A ; 4) SHOULDER ARTHROSCOPY, Pack Number BM230A ; 5) KNEE ARTHROSCOPY, Pack Number BM240A ; 6) PODIATRY PACK , Pack Number BM250A ; 7) CRANIOTOMY CDS, Pack Number CDS780025AA; 8) CRANIOTOMY CDS, Pack Number CDS780025AB; 9) CRANIOTOMY CDS, Pack Number CDS780025AC; 10) CRANIOTOMY CDS, Pack Number CDS780025X ; 11) CRANIOTOMY

Reported: September 18, 2024 Initiated: April 8, 2024 #Z-3052-2024

Product Description

Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY, Pack Number AM110A ; 3) HIP , Pack Number BM200A ; 4) SHOULDER ARTHROSCOPY, Pack Number BM230A ; 5) KNEE ARTHROSCOPY, Pack Number BM240A ; 6) PODIATRY PACK , Pack Number BM250A ; 7) CRANIOTOMY CDS, Pack Number CDS780025AA; 8) CRANIOTOMY CDS, Pack Number CDS780025AB; 9) CRANIOTOMY CDS, Pack Number CDS780025AC; 10) CRANIOTOMY CDS, Pack Number CDS780025X ; 11) CRANIOTOMY CDS, Pack Number CDS780025Y ; 12) LAMINECTOMY CDS-LF, Pack Number CDS780045M ; 13) LAMINECTOMY CDS-LF, Pack Number CDS780045N ; 14) LAMINECTOMY CDS-LF, Pack Number CDS780045O ; 15) CRANIOTOMY CDS, Pack Number CDS780046O ; 16) CRANI , Pack Number CDS780089V ; 17) CRANI , Pack Number CDS780089W ; 18) CRANI , Pack Number CDS780089X ; 19) CRANIOFACIAL CDS, Pack Number CDS780102K ; 20) CRANIOFACIAL CDS, Pack Number CDS780102L ; 21) TRAUMA/LIVER CDS-LF , Pack Number CDS780104L ; 22) CRANIOTOMY CDS-LF , Pack Number CDS780105K ; 23) CRANIOTOMY CDS-LF , Pack Number CDS780105L ; 24) NEURO LAMINECTOMY-LF, Pack Number CDS780109P ; 25) CRANIOTOMY-LF , Pack Number CDS780111M ; 26) CRANIOTOMY-LF , Pack Number CDS780111N ; 27) CRANIOTOMY-LF , Pack Number CDS780111O ; 28) CRANIOTOMY-LF , Pack Number CDS780111P ; 29) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119U ; 30) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119V ; 31) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119VH; 32) BASIC BACK CDS, Pack Number CDS780147K ; 33) INSTRUMENTED BACK CDS , Pack Number CDS780148O ; 34) LAMINECTOMY CDS , Pack Number CDS780165L ; 35) LAMINECTOMY CDS , Pack Number CDS780165M ; 36) LAMINECTOMY CDS , Pack Number CDS780165N ; 37) LAMINECTOMY CDS , Pack Number CDS780165O ; 38) LAMINECTOMY CDS , Pack Number CDS780165Q ; 39) LAMINECTOMY CDS , Pack Number CDS780165R ; 40) CRANIOTOMY CDS, Pack Number CDS780166Q ; 41) CRANIOTOMY CDS, Pack Number CDS780166R ; 42) CRANIOTOMY CDS, Pack Number CDS780166S ; 43) CRANIOTOMY CDS, Pack Number CDS780166T ; 44) CRANIOTOMY CDS, Pack Number CDS780166U ; 45) CRANIOTOMY CDS, Pack Number CDS780166V ; 46) DR WOLF SPINE CDS , Pack Number CDS780168P ; 47) GLENNON POSTERIOR SPINE FUSION, Pack Number CDS780182O ; 48) SPINAL FUSION CDS , Pack Number CDS780197N ; 49) SPINAL FUSION PACK, Pack Number CDS780197P ; 50) SPINAL FUSION PACK, Pack Number CDS780197Q ; 51) CRANIOT CRANIECT CDS, Pack Number CDS780201N ; 52) LAMINECTOMY CDS , Pack Number CDS780203J ; 53) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204P ; 54) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204Q ; 55) ANTERIOR CERVICAL CDS , Pack Number CDS780205O ; 56) ANTERIOR CERVICAL CDS , Pack Number CDS780205P ; 57) ANTERIOR CERVICAL CDS , Pack Number CDS780205Q ; 58) CRANIOTOMY CDS, Pack Number CDS780206O ; 59) CRANIOTOMY CDS, Pack Number CDS780206P ; 60) CRANIOTOMY CDS, Pack Number CDS780206R ; 61) ANTERIOR LUMBAR CDS , Pack Number CDS780207S ; 62) ANTERIOR LUMBAR CDS , Pack Number CDS780207T ; 63) NEURO-LAMI CDS, Pack Number CDS780208I ; 64) CRANIOTOMY PROCEDURE, Pack Number CDS780210I ; 65) CRANIOTOMY PROCEDURE, Pack Number CDS780210J ; 66) CRANIOTOMY PROCEDURE, Pack Number CDS780210K ; 67) SPINE CDS , Pack Number CDS780228D ; 68) LAMINECTOMY CDS-LF, Pack Number CDS780235V ; 69) LAMINECTOMY CDS-LF, Pack Number CDS780235W ; 70) LAMINECTOMY CDS-LF, Pack Number CDS780235X ; 71) SPINE CDS-LF, Pack Number CDS780236L ; 72) SPINE CDS-LF, Pack Number CDS780236M ; 73) CRANIOTOMY CDS-LF , Pack Number CDS780237K ; 74) CRANIOTOMY CDS-LF , Pack Number CDS780237L ; 75) SPINAL FUSION , Pack Number CDS860017AA; 76) SPINAL FUSION , Pack Number CDS860017AB; 77) SPINAL FUSION , Pack Number CDS860017AC; 78) FUSION CDS, Pack Number CDS860138D ; 79) FUSION CDS, Pack Number CDS860138F ; 80) FUSION CDS, Pack Number CDS860138G ; 81) LUMBAR, Pack Number CDS860170I ; 82) LUMBAR, Pack Number CDS860170J ; 83) LUMBAR, Pack Numbe

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) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY, Pack Number AM110A ; 3) HIP , Pack Number BM200A ; 4) SHOULDER ARTHROSCOPY, Pack Number BM230A ; 5) KNEE ARTHROSCOPY, Pack Number BM240A ; 6) PODIATRY PACK , Pack Number BM250A ; 7) CRANIOTOMY CDS, Pack Number CDS780025AA; 8) CRANIOTOMY CDS, Pack Number CDS780025AB; 9) CRANIOTOMY CDS, Pack Number CDS780025AC; 10) CRANIOTOMY CDS, Pack Number CDS780025X ; 11) CRANIOTOMY CDS, Pack Number CDS780025Y ; 12) LAMINECTOMY CDS-LF, Pack Number CDS780045M ; 13) LAMINECTOMY CDS-LF, Pack Number CDS780045N ; 14) LAMINECTOMY CDS-LF, Pack Number CDS780045O ; 15) CRANIOTOMY CDS, Pack Number CDS780046O ; 16) CRANI , Pack Number CDS780089V ; 17) CRANI , Pack Number CDS780089W ; 18) CRANI , Pack Number CDS780089X ; 19) CRANIOFACIAL CDS, Pack Number CDS780102K ; 20) CRANIOFACIAL CDS, Pack Number CDS780102L ; 21) TRAUMA/LIVER CDS-LF , Pack Number CDS780104L ; 22) CRANIOTOMY CDS-LF , Pack Number CDS780105K ; 23) CRANIOTOMY CDS-LF , Pack Number CDS780105L ; 24) NEURO LAMINECTOMY-LF, Pack Number CDS780109P ; 25) CRANIOTOMY-LF , Pack Number CDS780111M ; 26) CRANIOTOMY-LF , Pack Number CDS780111N ; 27) CRANIOTOMY-LF , Pack Number CDS780111O ; 28) CRANIOTOMY-LF , Pack Number CDS780111P ; 29) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119U ; 30) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119V ; 31) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119VH; 32) BASIC BACK CDS, Pack Number CDS780147K ; 33) INSTRUMENTED BACK CDS , Pack Number CDS780148O ; 34) LAMINECTOMY CDS , Pack Number CDS780165L ; 35) LAMINECTOMY CDS , Pack Number CDS780165M ; 36) LAMINECTOMY CDS , Pack Number CDS780165N ; 37) LAMINECTOMY CDS , Pack Number CDS780165O ; 38) LAMINECTOMY CDS , Pack Number CDS780165Q ; 39) LAMINECTOMY CDS , Pack Number CDS780165R ; 40) CRANIOTOMY CDS, Pack Number CDS780166Q ; 41) CRANIOTOMY CDS, Pack Number CDS780166R ; 42) CRANIOTOMY CDS, Pack Number CDS780166S ; 43) CRANIOTOMY CDS, Pack Number CDS780166T ; 44) CRANIOTOMY CDS, Pack Number CDS780166U ; 45) CRANIOTOMY CDS, Pack Number CDS780166V ; 46) DR WOLF SPINE CDS , Pack Number CDS780168P ; 47) GLENNON POSTERIOR SPINE FUSION, Pack Number CDS780182O ; 48) SPINAL FUSION CDS , Pack Number CDS780197N ; 49) SPINAL FUSION PACK, Pack Number CDS780197P ; 50) SPINAL FUSION PACK, Pack Number CDS780197Q ; 51) CRANIOT CRANIECT CDS, Pack Number CDS780201N ; 52) LAMINECTOMY CDS , Pack Number CDS780203J ; 53) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204P ; 54) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204Q ; 55) ANTERIOR CERVICAL CDS , Pack Number CDS780205O ; 56) ANTERIOR CERVICAL CDS , Pack Number CDS780205P ; 57) ANTERIOR CERVICAL CDS , Pack Number CDS780205Q ; 58) CRANIOTOMY CDS, Pack Number CDS780206O ; 59) CRANIOTOMY CDS, Pack Number CDS780206P ; 60) CRANIOTOMY CDS, Pack Number CDS780206R ; 61) ANTERIOR LUMBAR CDS , Pack Number CDS780207S ; 62) ANTERIOR LUMBAR CDS , Pack Number CDS780207T ; 63) NEURO-LAMI CDS, Pack Number CDS780208I ; 64) CRANIOTOMY PROCEDURE, Pack Number CDS780210I ; 65) CRANIOTOMY PROCEDURE, Pack Number CDS780210J ; 66) CRANIOTOMY PROCEDURE, Pack Number CDS780210K ; 67) SPINE CDS , Pack Number CDS780228D ; 68) LAMINECTOMY CDS-LF, Pack Number CDS780235V ; 69) LAMINECTOMY CDS-LF, Pack Number CDS780235W ; 70) LAMINECTOMY CDS-LF, Pack Number CDS780235X ; 71) SPINE CDS-LF, Pack Number CDS780236L ; 72) SPINE CDS-LF, Pack Number CDS780236M ; 73) CRANIOTOMY CDS-LF , Pack Number CDS780237K ; 74) CRANIOTOMY CDS-LF , Pack Number CDS780237L ; 75) SPINAL FUSION , Pack Number CDS860017AA; 76) SPINAL FUSION , Pack Number CDS860017AB; 77) SPINAL FUSION , Pack Number CDS860017AC; 78) FUSION CDS, Pack Number CDS860138D ; 79) FUSION CDS, Pack Number CDS860138F ; 80) FUSION CDS, Pack Number CDS860138G ; 81) LUMBAR, Pack Number CDS860170I ; 82) LUMBAR, Pack Number CDS860170J ; 83) LUMBAR, Pack Numbe. 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-3052-2024.

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