—#211378

Product

Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF DYNJ58648B; 2) ENDOSCOPIC SKULL BASE, REF DYNJ58648C; 3) ENT ENDO SINUS WILMINGTON PACK, REF DYNJ66447; 4) ENDOSCOPIC SKULL BASE, REF DYNJ58648D; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648J.

FDA product code: NWU — Endoscope Introducer Kit
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: 1) REF DYNJ58648B, UDI/DI 10193489624182 (EA) 40193489624183 (CS), Lot Numbers: 19BDB193; 2) REF DYNJ58648C, UDI/DI 10193489688542 (EA) 40193489688543 (CS), Lot Numbers: 19EDD585, 19IDA770, 20AMA033, 20AMC750, 20EMB449; 3) REF DYNJ66447, UDI/DI 10193489367379 (EA) 40193489367370 (CS), Lot Numbers: 20KMC595, 21AMB129; 4) REF DYNJ58648D, UDI/DI 10195327212124 (EA) 40195327212125 (CS), Lot Numbers: 22KMD675, 23DMD129, 23HMG766, 23JMD938; 5) REF DYNJ58648J, UDI/DI 10193489356793 (EA) 40193489356794 (CS), Lot Numbers: 20EBN856, 20JBG508, 20JBK503, 20JBT975, 20KBQ270, 21ABK829, 21EBP637, 21EBP646, 21JBO555, 21KBC098, 21KBV126, 21LBP144.

Why it was recalled

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Medline issued a MEDICAL DEVICE VOLUNTARY RECALL notice on 11/21/2024 to its consignees via US Mail and email. The notice explained the issue, potential risk to health, and requested that the affected product be quarantined. Once the response is received, Medline will provide labels to place on affected inventory, with instructions for the consignee to remove the affected component prior to using the kit.

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 UAE, and Canada.

Timeline

Recall initiated: 2024-11-21
Posted by FDA: 2024-12-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211378. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.