Recall Z-1094-2023— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2022-11-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOTICS PACK-LF e. ROBOTIC PACK f. PELVISCOPY PACK-LF g. CUSTOM LITHOTOMY ROBOT PACK h. PERI GYN PACK i. ROBOTICS PACK j. LAP HYSTO PACK k. PK, ROBOTICS-ACCESSORY l. OBS PACK m. LAPAROSCOPY/D&C PACK n. PERI GYN RECTAL PACK o. TVT p. DAVINCI DT-LF q. ROBOTICS SI. Reason: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-17
- Firm location
- Northfield, IL, United States
Product description
Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOTICS PACK-LF e. ROBOTIC PACK f. PELVISCOPY PACK-LF g. CUSTOM LITHOTOMY ROBOT PACK h. PERI GYN PACK i. ROBOTICS PACK j. LAP HYSTO PACK k. PK, ROBOTICS-ACCESSORY l. OBS PACK m. LAPAROSCOPY/D&C PACK n. PERI GYN RECTAL PACK o. TVT p. DAVINCI DT-LF q. ROBOTICS SI
Reason for recall
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Data sourced from openFDA. This site is unofficial and independent of the FDA.