Custom Sterile and Non-Sterile Procedural Kits recall: Sterility Concern

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ902507B, UPC Number: 088994278118. b. Model Number: DYNJ46043D, UPC Number: 019348935036; Model Number: DYNJ46043F, UPC Number: 019348985672. c. Model Number: DYNJ43609K, UPC Number: 019348950140; Model Number: DYNJ43609L, UPC Number 019348960178; Model Number: DYNJ43609M, UPC Number 019348962744; Model Number: DYNJ43609N, UPC Number 019348928212. d. Model Number: DYNJ17624B, UPC Number: 019348986729; Model Number: DYNJ44320F, UPC Number 019348943551. e. Model Number: DYNJ47951A, UPC Number: 019348960984. f. Model Number: DYNJ40632C, UPC Number: 019348946117. g. Model Number: DYNJ30141, UPC Number: 019348956435; Model Number: DYNJ34361, UPC Number 088438934847; Model Number: DYNJ42903B, UPC Number: 088827779801; Model Number: DYNJ43661B, UPC Number 088994280870; Model Number: DYNJ47226A, UPC Number: 088827756181; Model Number: DYNJ50624A, UPC Number 088994247463; Model Number: DYNJ51239A, UPC Number: 088994249354; Model Number: DYNJ58111C, UPC Number 019348984600; Model Number: DYNJ58126A, UPC Number: 019348948475; Model Number: DYNJ62299, UPC Number 019348964151; Model Number: DYNJ62544, UPC Number: 019348966652; Model Number: DYNJ65043A, UPC Number 019348937932; Model Number: DYNJ66398A, UPC Number: 019348941416; Model Number: DYNJ66398B, UPC Number 019348989192. h. Model Number: DYNJ60507A, UPC Number: 019348983055. i. Model Number: DYNJ0373279L, UPC Number: 019348956435; Model Number: DYNJ0373279M, UPC Number: 019348951902. j. Model Number: DYNJ46153A, UPC Number: 088994218586; Model Number: DYNJ46153B, UPC Number: 019348985364; Model Number: DYNJ52121, UPC Number: 088994224362. k. Model Number: DYNJ62742, UPC Number: 019348968592, Lot Numbers: 21LBP049, 22OBH570, 22EBP081, 22FBG069, 20XBB252, 21BBH070, 21DBJ756. l. Model Number: DYNJ36049, UPC Number: 019348956435. m. Model Number: DYNJ0149444M, UPC Number: 019348956435. n. Model Number: DYNJ45007, UPC Number: 088827708541; Model Number: DYNJ47004C, UPC Number: 019348969617; Model Number: DYNJ66244, UPC Number: 019348932371. o. Model Number: DYNJ33638K, UPC Number: 019348934328. p. Model Number: DYNJ49621B, UPC Number: 088994228223; Model Number: DYNJ63060A, UPC Number: 019348942308; Model Number: DYNJ63684F, UPC Number: 019348989720; Model Number: DYNJ68065, UPC Number: 019348947511; Model Number: DYNJ68065A, UPC Number: 019348988872; Model Number: DYNJT2344B, UPC Number: 088994210780. q. Model Number: DYNJ28067G, UPC Number: 088994274429; Model Number: DYNJVB1135A, UPC Number: 019348933993. r. Model Number: 00-401318L, UPC Number: 088827709176; Model Number: 00-401318M, UPC Number: 019348934875. s. Model Number: CDS984944C, UPC Number: 088994217295. t. Model Number: DYNJ44293D, UPC Number: 019348983341; Model Number: DYNJ47906, UPC Number: 088827752837; Model Number: DYNJ55252B, UPC Number: 019348987015; Model Number: DYNJ57498, UPC Number: 088994274574; Model Number: DYNJ65190C, UPC Number: 019348943311; Model Number: DYNJ66476, UPC Number: 019348935677; Model Number: DYNJC2371G, UPC Number: 088994249467. u. Model Number: DYNJ0854485T, UPC Number: 019348986419. v. Model Number: DYNJ43203F, UPC Number: 019348939286; Model Number: DYNJ64655A, UPC Number: 019348986331. w. Model Number: DYNJ65185, UPC Number: 019348925314. x. Model Number: DYNJ62379, UPC Number: 019348965170. y. Model Number: DYNJ41649F, UPC Number: 019348964127. z. Model Number: DYNJ42367A, UPC Number: 088827794377. aa. Model Number: DYNJ33457C, UPC Number: 019348946180. bb. Model Number: DYNJ68758, UPC Number: 019348983756. cc. Model Number: DYNJ63527, UPC Number: 019348974839. dd. Model Number: DYNJ62379, UPC Number: 019348965170. ee. Model Number: DYNJ19939M, UPC Number: 019348939324. ff. Model Number: DYNJ49931F, UPC Number: 019348947166. gg. Model Number: DYNJ906354C, UPC Number: 019348981670. hh. Model Number: DYNJ24225K, UPC Number: 088994251070. ii. Model Number: DYNJ61015B, UPC Number: 019348936888. jj. Model Number: DYNJ42499C, UPC Number: 019532703086. kk. Model Number: DYNJ57760B, UPC Number: 019348934258. ll. Model Number: DYNJ59465B, UPC Number: 019348947093. mm. Model Number: DYNJ0806254D, UPC Number: 088994247116. nn. Model Number: DYNJ37665B, UPC Number: 088994296973. oo. Model Number: WK100B, UPC Number: 019348934875. pp. Model Number: DYNJ49884B, UPC Number: 088994236366; Model Number: DYNJ49884F, UPC Number: 019348946957. qq. Model Number: DYNJ41553D, UPC Number: 088994281133. rr. Model Number: DYNJ60319A, UPC Number: 019348927629. ss. Model Number: DYNJ67245, UPC Number: 019348939305. tt. Model Number: DYNJ65482A, UPC Number: 019348941682. uu. Model Number: PHS41743D, UPC Number: 019348945327. vv. Model Number: DYNJ54755D, UPC Number: 019348943426; Model Number: DYNJ54755F, UPC Number: 019348988460. ww. Model Number: DYNJ60112, UPC Number: 088827779984. xx. Model Number: DYNJ57645A, UPC Number: 019348955794; Model Number: DYNJ57645B, UPC Number: 019348982865. yy. Model Number: DYNJ61747A, UPC Number: 019348971965. zz. Model Number: DYNJ64830, UPC Number: 019348922313. aaa. Model Number: DYNJ66500, UPC Number: 019348935791. bbb. Model Number: DYNJ0201109AG, UPC Number: 019348949726.

Product

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ902507B; b.…

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Quantity

63,823 kits

Distribution

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

Recall date

August 9, 2023

Classification

Class II

Status

Ongoing

Agency

FDA (device)