Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Recalled by MEDLINE INDUSTRIES, LP - Northfield Due to Potential for the labeled sterile ultrasound gel component...

Date: May 15, 2023
Company: MEDLINE INDUSTRIES, LP - Northfield
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact MEDLINE INDUSTRIES, LP - Northfield directly.

Affected Products

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ902507B; b. ANGIO BASIN SET, Model Numbers: DYNJ46043D, DYNJ46043F; c. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609K, DYNJ43609L, DYNJ43609M, DYNJ43609N; d. ANGIO DRAPE PACK, Model Number: DYNJ17624B, DYNJ44320F; e. ANGIO DRAPE SPEC PROC PACK, Model Number: DYNJ47951A; f. ANGIO LEFT HEART PACK, Model Number: DYNJ40632C; g. ANGIO PACK, Model Numbers: DYNJ30141, DYNJ34361, DYNJ42903B, DYNJ43661B, DYNJ47226A, DYNJ50624A, DYNJ51239A, DYNJ58111C, DYNJ58126A, DYNJ62299, DYNJ62544, DYNJ65043A, DYNJ66398A, DYNJ66398B; h. ANGIO PACK 2-A, Model Number: DYNJ60507A; i. ANGIO PACK-LF, Model Numbers: DYNJ0373279L, DYNJ0373279M; j. ANGIO TRAY, Model Numbers: DYNJ46153A, DYNJ46153B, DYNJ52121; k. ANGIO TRAY W/CHLORAPREP, Model Number: DYNJ62742; l. ANGIO/PICC PACK, Model Number: DYNJ36049; m. ANGIOGRAM, Model Number: DYNJ0149444M; n. ANGIOGRAM PACK, Model Numbers: DYNJ45007, DYNJ47004C, DYNJ66244; o. ANGIOGRAM TRAY, Model Number: DYNJ33638K; p. ANGIOGRAPHY DRAPE PACK, Model Numbers: DYNJ49621B, DYNJ63060A, DYNJ63684F, DYNJ68065, DYNJ68065A, DYNJT2344B; q. ANGIOGRAPHY DRAPE PACK-LF, Model Numbers: DYNJ28067G, DYNJVB1135A; r. ANGIOGRAPHY DRP PK PEDI CATH, Model Numbers: 00-401318L, 00-401318M; s. ANGIOGRAPHY OR, Model Number: CDS984944C; t. ANGIOGRAPHY PACK, Model Numbers: DYNJ44293D, DYNJ47906, DYNJ55252B, DYNJ57498, DYNJ65190C, DYNJ66476, DYNJC2371G; u. ANGIOGRAPHY PACK-LF, Model Number: DYNJ0854485T; v. ANGIOPLASTY PACK-LF, Model Numbers: DYNJ43203F, DYNJ64655A; w. CATH LAB PACK, Model Number: DYNJ65185; x. CLOVIS CATH LAB PACK, Model Number: DYNJ62379; y. CUSTOM ANGIO TRAY, Model Number: DYNJ41649F; z. CVOR ANGIOGRAPHY PACK-LF, Model Number: DYNJ42367A; aa. DASHTI-YAO NEURO ANGIO-LF, Model Number: DYNJ33457C; bb. DBD-ANGIO TRAY, Model Number: DYNJ68758; cc. DBD-CATH PACK, Model Number: DYNJ63527; dd. DBD-CLOVIS CATH LAB PACK, Model Number: DYNJ62379; ee. DEPAUL ANGIO PACK, Model Number: DYNJ19939M; ff. EH VASCULAR ANGIO, Model Number: DYNJ49931F; gg. ENDOVASCULAR KIT, Model Number: DYNJ906354C; hh. EP ANGIOGRAPHY PACK, Model Number: DYNJ24225K; ii. FEMORAL ANGIOGRAPY SET UP, Model Number: DYNJ61015B; jj. FS ANGIO, Model Number: DYNJ42499C; kk. GENERAL ANGIO PACK, Model Number: DYNJ57760B; ll. HH ANGIO PACK, Model Number: DYNJ59465B; mm. IPMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0806254D; nn. IR MINOR ANGIO PACK, Model Number: DYNJ37665B; oo. KENNESTONE ANGIO, Model Number: WK100B; pp. MH HOOD CARDIAC ANGIO, Model Numbers: DYNJ49884B, DYNJ49884F; qq. MV-IR ANGIO DRAPE PACK-LF, Model Number: DYNJ41553D; rr. OR ANGIO PACK, Model Number: DYNJ60319A; ss. OR ANGIOGRAPHY PACK, Model Number: DYNJ67245; tt. PACK,BASIC ANGIO, Model Number: DYNJ65482A; uu. PEDI ANGIO PACK-LF, Model Number: PHS41743D; vv. PEDIATRIC CATH ANGIO PACK, Model Numbers: DYNJ54755D, DYNJ54755F; ww. PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112; xx. PERCUTANEOUS ANGIO PACK-LF, Model Numbers: DYNJ57645A, DYNJ57645B; yy. PORT PACK, Model Number: DYNJ61747A; zz. SUNSHINE PACK, Model Number: DYNJ64830; aaa. SURGERY ANGIO PACK-LF, Model Number: DYNJ66500; bbb. VASCULAR ANGIO PACK-LF, Model Numbers: DYNJ0201109AG

Quantity: 63,823 kits

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About MEDLINE INDUSTRIES, LP - Northfield

MEDLINE INDUSTRIES, LP - Northfield has 822 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report