BEUDAMED
    FDA Enforcement Class II Ongoing

    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;

    Recall: Z-2338-2023 · Reported August 9, 2023

    Enforcement

    Recall Number
    Z-2338-2023
    Event ID
    92399
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 9, 2023
    Initiation Date
    May 15, 2023
    Classification Date
    August 3, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    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;

    Reason

    Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

    Code Info

    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.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

    Quantity

    15,323 kits