PlainRecalls
FDA Devices Moderate Class II Ongoing

Medline Convenience kits labeled as: 1) STEREOTACTIC BREAST BIOPSY TRA, Pack Number BT1095 ; 2) BREAST BIOPSY TRAY, Pack Number MNS5070; 3) BREAST BIOPSY TRAY-LF, Pack Number SPEC0058A; 4) BREAST BIOPSY TRAY, Pack Number DYNDH1142A; 5) BREAST BIOPSY TRAY, Pack Number SPEC0130B; 6) BIOPSY PACK SM, Pack Number DYNDH1093; 7) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A; 8) MAMMOGRAPHY BIOPSY TRAY, Pack Number DYNDH1304A; 9) LACERATION TRAY, Pack Number DYNDL1250C; 10) PULL D/

Reported: September 18, 2024 Initiated: April 8, 2024 #Z-3030-2024

Product Description

Medline Convenience kits labeled as: 1) STEREOTACTIC BREAST BIOPSY TRA, Pack Number BT1095 ; 2) BREAST BIOPSY TRAY, Pack Number MNS5070; 3) BREAST BIOPSY TRAY-LF, Pack Number SPEC0058A; 4) BREAST BIOPSY TRAY, Pack Number DYNDH1142A; 5) BREAST BIOPSY TRAY, Pack Number SPEC0130B; 6) BIOPSY PACK SM, Pack Number DYNDH1093; 7) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A; 8) MAMMOGRAPHY BIOPSY TRAY, Pack Number DYNDH1304A; 9) LACERATION TRAY, Pack Number DYNDL1250C; 10) PULL D/C PACK, Pack Number DYNDA2080; 11) DIAGNOSTIC TRAY, Pack Number DYNDH1359; 12) OB DELIVERY SET, Pack Number MNS3355; 13) SUTURING SET, Pack Number SUT4020; 14) 22G FACET TRAY, Pack Number SPEC0265A; 15) ARTHROGRAM TRAY, Pack Number DYNDH1349; 16) BIOPSY TRAY W/O LIDOCAINE, Pack Number SPEC0196B; 17) ULTRASOUND BREAST BIOPSY, Pack Number DYNDH1496; 18) BREAST BIOPSY TRAY, Pack Number SPEC0130C; 19) DELIVERY ACCESSORY KIT, Pack Number MNS6496; 20) BREAST BIOPSY KIT, Pack Number DYNDH1706; 21) BIOPSY TRAY - LF, Pack Number DYNJTS0018A; 22) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 23) STEREOTACTIC BREAST BIOPSY TRAY, Pack Number DYNDH1755; 24) BREAST BIOPSY, Pack Number DYNDH1518A; 25) PORT INSERTION KIT, Pack Number MNS11590; 26) CORE BIOPSY TRAY, Pack Number SPEC0083B; 27) INFUSION CENTER BLOOD DRAW KIT, Pack Number DYNDH1798; 28) BREAST CENTER BIOPSY TRAY, Pack Number DYNDH1519; 29) AULTMAN HOSPITAL CHEST TUBE INSERTION TR, Pack Number CHT500; 30) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 31) ARTHROGRAM TRAY, Pack Number DYNDH1134; 32) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 33) BIOPSY TRAY, Pack Number DYNDH1269; 34) BIOPSY BASIC PACK, Pack Number DYNDH1588

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) STEREOTACTIC BREAST BIOPSY TRA, Pack Number BT1095 ; 2) BREAST BIOPSY TRAY, Pack Number MNS5070; 3) BREAST BIOPSY TRAY-LF, Pack Number SPEC0058A; 4) BREAST BIOPSY TRAY, Pack Number DYNDH1142A; 5) BREAST BIOPSY TRAY, Pack Number SPEC0130B; 6) BIOPSY PACK SM, Pack Number DYNDH1093; 7) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A; 8) MAMMOGRAPHY BIOPSY TRAY, Pack Number DYNDH1304A; 9) LACERATION TRAY, Pack Number DYNDL1250C; 10) PULL D/C PACK, Pack Number DYNDA2080; 11) DIAGNOSTIC TRAY, Pack Number DYNDH1359; 12) OB DELIVERY SET, Pack Number MNS3355; 13) SUTURING SET, Pack Number SUT4020; 14) 22G FACET TRAY, Pack Number SPEC0265A; 15) ARTHROGRAM TRAY, Pack Number DYNDH1349; 16) BIOPSY TRAY W/O LIDOCAINE, Pack Number SPEC0196B; 17) ULTRASOUND BREAST BIOPSY, Pack Number DYNDH1496; 18) BREAST BIOPSY TRAY, Pack Number SPEC0130C; 19) DELIVERY ACCESSORY KIT, Pack Number MNS6496; 20) BREAST BIOPSY KIT, Pack Number DYNDH1706; 21) BIOPSY TRAY - LF, Pack Number DYNJTS0018A; 22) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 23) STEREOTACTIC BREAST BIOPSY TRAY, Pack Number DYNDH1755; 24) BREAST BIOPSY, Pack Number DYNDH1518A; 25) PORT INSERTION KIT, Pack Number MNS11590; 26) CORE BIOPSY TRAY, Pack Number SPEC0083B; 27) INFUSION CENTER BLOOD DRAW KIT, Pack Number DYNDH1798; 28) BREAST CENTER BIOPSY TRAY, Pack Number DYNDH1519; 29) AULTMAN HOSPITAL CHEST TUBE INSERTION TR, Pack Number CHT500; 30) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 31) ARTHROGRAM TRAY, Pack Number DYNDH1134; 32) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 33) BIOPSY TRAY, Pack Number DYNDH1269; 34) BIOPSY BASIC PACK, Pack Number DYNDH1588. 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-3030-2024.