Z-2309-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 9, 2023
- Initiation Date
- May 15, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,431 kits
Product Description
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CAROTID, Model Number: DYNJ54287A; b. CAROTID PACK, Model Number: DYNJ66190; c. CAROTID SUPPLY, Model Number: DYNJ905622C; d. CAROTID-LF, Model Number: DYNJ901745J; e. CENTRAL LINE INSERTION, Model Number: DYNJ63347A; f. CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; g. DBD-CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; h. DBD-IR THYROID PACK THLUF642-LF, Model Number: DYNJ47716B; i. ENT FREE FLAP, Model Number: SYNJ910018A; j. ENT FREE FLAP PACK, Model Number: DYNJ67954A; k. FEM CAROTID PACK, Model Number: DYNJ65706; l. FLAP ENT FREE, Model Number: DYNJ905340A; m. FREE FLAP PACK-LF, Model Number: DYNJ20495J; n. PACK HEAD NECK, Model Number: DYNJ30245; o. SVMMC CAROTID PACK, Model Number: DYNJ43861D; p. TAVR FAIRFAX, Model Number: DYNJ63634A; q. VNUS TRAY, Model Number: DYNJ44410F;
Reason for Recall
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
Code Information
All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ54287A, UPC Number: 088994276521. b. Model Number: DYNJ66190, UPC Number: 019348932219. c. Model Number: DYNJ905622C, UPC Number: 019348926350. d. Model Number: DYNJ901745J, UPC Number: 019348960482. e. Model Number: DYNJ63347A, UPC Number: 019348927806. f. Model Number: CDS983069G, UPC Number: 019348992392. g. Model Number: CDS983069I, UPC Number: 019532707186. h. Model Number: DYNJ47716B, UPC Number: 019348945453. i. Model Number: SYNJ910018A, UPC Number: 019348937418. j. Model Number: DYNJ67954A, UPC Number: 019348995714. k. Model Number: DYNJ65706, UPC Number: 019348928490. l. Model Number: DYNJ905340A, UPC Number: 019348950213. m. Model Number: DYNJ20495J, UPC Number: 019348956435. n. Model Number: DYNJ30245, UPC Number: 008019678769. o. Model Number: DYNJ43861D, UPC Number: 088994276328. p. Model Number: DYNJ63634A, UPC Number: 019532714304. q. Model Number: DYNJ44410F, UPC Number: 019348981154.