Class 2 Device Recall

• Date Initiated by Firm: May 15, 2023
• Date Posted: August 03, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2338-2023
• Recall Event ID: 92399
• Product Classification: Orthopedic tray - Product Code OJH
• Product: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: ; ; a. ANGIOGRAPHY PACK, Model Number: DYNJ65963A; ; ; b. ARTHOGRAM TRAY, Model Number: PAIN1524B; ; ; c. ARTHROGRAM TRAY, Model Number: PAIN1524A;; ; d. CARPAL TUNNEL KIT, Model Number: DYNJ63149A; ; ; e. CRANIOTOMY CDS, Model Number: CDS981753L; ; ; f. CRANIOTOMY CDS-1, Model Number: CDS982889I; ; ; g. CRANIOTOMY PACK, Model Number: DYNJ61749A; ; ; h. DBD-JOINT INJECTION TRAY, Model Number: DYNDH1722; ; ; i. ENS STERILE POUR IMPLANT-LF, Model Number: OST011E; ; ; j. FREE FLAP LOWER EXT-LF, Model Number: DYNJ909168; ; ; k. FREE FLAP UPPER EXT-LF, Model Number: DYNJ909169; ; ; l. HYBRID PACK, Model Number: DYNJ56907D; ; ; m. IR ARM PACK, Model Number: DYNJ50712C; ; ; n. LOWER EXTREMITY BLOCK PACK-RX, Model Number: SPEC0204D; ; ; o. MURRIETA PACK, Model Number: DYNJ69312, DYNJ69312A; ; ; p. OASC IVF PACK, Model Number: DYNJ53035B; ; ; q. PERIPHERAL NERVE BLOCK KIT, Model Number: DYNJRA1619; ; ; r. RO VASCULAR EXTREMITY PK-LF, Model Number: PHS392881009C; ; ; s. SCO ARTHROSCOPY, Model Number: DYNJ906551A; ; ; t. SHOULDER BLOCK KIT , Model Number: DYKS1241A; ; ; u. SHOULDER PACK-LF, Model Number: PHS41748D; ; ; v. TAA AAA, Model Number: DYNJ63339D; ; ; w. TOTAL HIP PACK-LF, Model Number: DYNJ51672J, DYNJ51672K, DYNJ51672L; ; ; x. TOTAL KNEE REPLACEMENT, Model Number: DYNJ908420; ; ; y. TUNNEL PACK, Model Number: DYNJ58127B; ; ; z. UPPER EXTREMITY BLOCK PACK-RX, Model Number: SPEC0205F; ; ; aa. US JOINT KIT, Model Number: DYNJRA1944; ; ; bb. VASCULAR EXTREMITY PACK, Model Number: DYNJ63373B, DYNJ63373C, DYNJ63373D, DYNJ63373F
• 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: DYNJ65963A, UPC Number: 019348999205. b. Model Number: PAIN1524B, UPC Number: 019348999446. c. Model Number: PAIN1524A, UPC Number: 019348932800. d. Model Number: DYNJ63149A, UPC Number: 019348978647. e. Model Number: CDS981753L, UPC Number: 019532723862. f. Model Number: CDS982889I, UPC Number: 088994220806. g. Model Number: DYNJ61749A, UPC Number: 019532706301. h. Model Number: DYNDH1722, UPC Number: 019532713216. i. Model Number: OST011E, UPC Number: 088827758932. j. Model Number: DYNJ909168, UPC Number: 019532728659. k. Model Number: DYNJ909169, UPC Number: 019532728660. l. Model Number: DYNJ56907D, UPC Number: 019348983156. m. Model Number: DYNJ50712C, UPC Number: 019348987016. n. Model Number: SPEC0204D, UPC Number: 019348930298. o. Model Number: DYNJ69312, UPC Number: 019348992946; Model Number: DYNJ69312A, UPC Number: 019532721677. p. Model Number: DYNJ53035B, UPC Number: 088827776381. q. Model Number: DYNJRA1619, UPC Number: 019348931184. r. Model Number: PHS392881009C, UPC Number: 019348922233. s. Model Number: DYNJ906551A, UPC Number: 019532712408. t. Model Number: DYKS1241A, UPC Number: 019348948809. u. Model Number: PHS41748D, UPC Number: 019348978479. v. Model Number: DYNJ63339D, UPC Number: 019532727360. w. Model Number: DYNJ51672J, UPC Number: 019348958962; Model Number: DYNJ51672K, UPC Number: 019532711224; Model Number: DYNJ51672L, UPC Number: 019532722130. x. Model Number: DYNJ908420, UPC Number: 019532707336. y. Model Number: DYNJ58127B, UPC Number: 019348948279. z. Model Number: SPEC0205F, UPC Number: 019348921288. aa. Model Number: DYNJRA1944, UPC Number: 019532713304. bb. Model Number: DYNJ63373B, UPC Number: 019348929206; Model Number: DYNJ63373C, UPC Number: 019348995812; Model Number: DYNJ63373D, UPC Number: 019532708615; Model Number: DYNJ63373F, UPC Number: 019532727078.
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Karin Johnson; 886-359-1704
• Manufacturer Reason for Recall: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Medline notified customers beginning on 05/15/2023, via mail and email with letter. Customers with Medline Probe Cover Kits were instructed to check inventory for affected kits, destroy any affected kits, and complete and return the response form. Distributors were instructed to notify their customers and have them document and destroy affected kits. Customers with the non-sterile and sterile procedural kits were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits. Distributors were instructed to notify customers of the recall and have customers return any affected product for return to Medline. Medline identified additional units of Medline Probe Cover Kits and notified customers on 06/22/2023. Customers were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits.
• Quantity in Commerce: 15,323 kits
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.