—#200702

Product

Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE5900; b. COVER, PROBE, W/GEL AND BANDS, 6X24 - Model Number DYNJE5910; c. COVER, PROBE, W/GEL AND BANDS, 6X48 - Model Number DYNJE5920; d. COVER, PROBE, W/GEL AND BANDS, 6X96 - Model Number DYNJE5930; e. COVER, PROBE, W/GEL AND BANDS, 5X48 - Model Number DYNJE5940; f. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJEX5900

FDA product code: MMP — Cover, Barrier, Protective
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K032065, K130581
Affected lot / code info: a. Model Number DYNJE5900; UDI-DI Each: 10884389114124, Case: 40884389114125; Lot Numbers: 06920030012, 06920030021, 06920040022, 06920050011, 06920050011, 06920050011, 06920050011, 06920050011, 06920050011, 06920070011, 06920080012, 06920100011, 06920100011, 06920110011, 06920120011, 06920120011, 06921010011, 06921010011, 06921010022, 06921020011, 06921020021, 06921030021, 06921030031, 06921040011, 06921040011, 06921040011, 06921040011, 06921040011, 06921050011, 06921050011, 06921060011, 06921070011, 06921070011, 06921080011, 06921080011, 06921090011, 06921090012, 06921100011, 06921100012, 06921100012, 06921110011, 0692112H022, 0692112H022, 0692112H022, 0692201H011, 0692202H011, 0692202H011, 0692202H024, 0692202H024, 0692204H011, 0692204H011, 0692205H011, 0692205H011, 0692205H011, 0692205H011; b. Model Number DYNJE5910; UDI-DI Each: 10884389114094, Case: 40884389114095; Lot Numbers: 06920120011, 06920120011, 06921010011, 06921030011, 06921040011, 06921040011, 06921040011, 06921040011, 06921040011, 06921040011, 06921060011, 06921070011, 06921070011, 06921080011, 06921080011, 06921090011, 06921110011, 06921120011, 0692112H022, 0692112H022, 0692202H011, 0692202H011, 0692202H024, 0692202H024, 0692204H011, 0692204H011, 0692205H011, 0692205H011, 0692208H014; c. Model Number DYNJE5920; UDI-DI Each: 10884389114100, Case: 40884389114101; Lot Numbers: 06920030012, 06920030021, 06920040022, 06920040022, 06920050011, 06920050011, 06920050011, 06920070011, 06920080012, 06920090011, 06920100011, 06920100011, 06920110011, 06920120011, 06920120011, 06920120012, 06921010011, 06921020021, 06921030012, 06921030021, 06921030021, 06921040011, 06921040011, 06921040011, 06921040011, 06921040011, 06921050011, 06921060011, 06921070011, 06921070011, 06921080011, 06921080011, 06921090011, 06921100011, 06921100012, 06921100013, 06921110011, 0692112H022, 0692112H022, 0692112H022, 0692202H011, 0692202H024, 0692203H011, 0692204H011, 0692204H011, 0692205H011, 0692205H012, 0692205H013, 0692205H013, 0692206H011; d. Model Number DYNJE5930; UDI-DI Each: 10884389114117, Case: 40884389114118; Lot Numbers: 06920030012, 06920030021, 06920040022, 06920040022, 06920050011, 06920050011, 06920050011, 06920050012, 06920070011, 06920080012, 06920100011, 06920110011, 06920110011, 06920110011, 06920120011, 06920120011, 06921010011, 06921010011, 06921010011, 06921020021, 06921030021, 06921040011, 06921040011, 06921040011, 06921050011, 06921060011, 06921070011, 06921070011, 06921080011, 06921080011, 06921090011, 06921090011, 06921090012, 06921100011, 06921100012, 06921100012, 06921120011, 0692112H022, 0692202H011, 0692202H011, 0692202H024, 0692202H024, 0692203H011, 0692204H011, 0692204H011, 0692205H011, 0692205H011, 0692205H011, 0692205H011, 0692206H011; e. Model Number DYNJE5940; UDI-DI Each: 10888277723641, Case: 20888277723648; Lot numbers: 06920050011, 06920060012, 06920060012, 06920070021, 06920100011, 06920110011, 06920110011, 06920110011, 06920110012, 06920120011, 06921050011, 06921050011, 06921060011, 06921070011, 06921070011, 06921080011, 0692201H011, 0692202H011, 0692202H011, 0692202H024, 0692202H024, 0692203H011, 0692203H011, 0692204H011, 0692204H011; f. Model Number DYNJEX5900; UDI-DI Each: 10884389114124, Case: 40884389114125; Lot Numbers: 06920040022, 06920080012. **Lot format as follows: Example 069YYMM0001 where "069" is the last 3 digits of the vendor code for the probe cover kitting facility, "YYMM" is the year and month of manufacture of the probe cover kit, and "0001" is a sequential number for the month of production

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

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

Timeline

Recall initiated: 2023-05-15
Posted by FDA: 2023-08-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #200702. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.