Recall Z-2158-2023— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-2158-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-18

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2023-05-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220; b) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773; c) PERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B; d) PERI NEURO BLOCK PACK-LF, Model Number DYNJ0703127A; e) PERI NEURO BLOCK PACK-LF, Model Number DYNJ42367B; f) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1571; g) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJRA0656A; h) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJ47338; i) BLOCK KIT-LF, Model Number DYNJRA1287A; j) BLOCK KIT-LF, Model Number PAIN1622A; k) BLOCK KIT-LF, Model Number DYNJRA1543; l) PK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1635A; m) PK, RADIOLOGY-NEURO-IR, Model Number DYNJ0134147D; n) PK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1604; o) BLOCK TRAY, Model Number PAIN1182;. Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2023-05-18
Firm location: Northfield, IL, United States

Product description

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220; b) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773; c) PERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B; d) PERI NEURO BLOCK PACK-LF, Model Number DYNJ0703127A; e) PERI NEURO BLOCK PACK-LF, Model Number DYNJ42367B; f) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1571; g) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJRA0656A; h) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJ47338; i) BLOCK KIT-LF, Model Number DYNJRA1287A; j) BLOCK KIT-LF, Model Number PAIN1622A; k) BLOCK KIT-LF, Model Number DYNJRA1543; l) PK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1635A; m) PK, RADIOLOGY-NEURO-IR, Model Number DYNJ0134147D; n) PK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1604; o) BLOCK TRAY, Model Number PAIN1182;

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Data sourced from openFDA. This site is unofficial and independent of the FDA.