—#209514

Product

Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1937CR.

FDA product code: NUJ — Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K182588
Affected lot / code info: Item Number: LF1937CR. UDI/DI: 20888277719412 (case), 10888277719415 (each). Lot Numbers: 487233, 487315, 500686, 500687, 500963, 507070, 507116, 507420, 507423, 507424, 513684, 513691, 513692, 513998, 513999, 514002, 514004, 514006, 514205, 514206, 514332, 514337, 514343, 514540, 514542, 514631, 514633, 514634, 514873, 514874, 514875, 514876, 514877, 514878, 514879, 514880, 514881, 514882, 514883, 514884, 514885, 514886, 514887, 514939, 515183, 515184, 515185, 515186, 515238, 515239, 515240, 515241, 515246, 515247, 515248, 515249, 515281, 515282, 515283, 515284, 515285, 515433, 515461, 515462, 515463, 515464, 515519, 515520, 515521, 515522, 515523, 515524, 515525, 515527, 515561, 515562, 515563, 515564, 515565, 515566, 515568, 515569, 515760, 515762, 515764, 515765, 515766, 515767, 515768, 515832, 515834, 515835, 515836, 515837, 515838, 515839, 515840, 515841, 515842, 515843, 515844, 515963, 515991, 515992, 515993, 515994, 515995, 515996, 515997, 516002, 516087, 516088, 516091, 516092, 516156, 516163, 516164, 516165, 516214, 516215, 516216, 516217, 516218, 516219, 516220, 516221, 516223, 516261, 516262, 516267, 516270, 516273, 516276, 516277, 516393, 516401, 516402, 516404, 516491, 516492, 516493, 516494, 516495, 516497, 516498, 516499, 516500, 516501, 516503, 516504, 516505, 516541, 516542, 516543, 516544, 516545, 516721, 516722, 516723, 516728, 516729, 516730, 516731, 516740, 516745, 516746, 516749, 516752, 516754, 516756, 516870, 516872, 516882, 516883, 517086, 517094, 517933, 517935, 517936, 517940, 517944, 517945, 518078, 518079, 518080, 518081, 518082, 518147, 518148, 518149, 518150, 518151, 518293, 518294, 518296, 518297, 518546, 518550, 518553, 518556, 518622, 518624, 518625.

Why it was recalled

Potential for an incomplete seal on the packaging tray.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline notified consignees on about 05/06/2024 via letter sent email or First-Class mail. Consignees were instructed to examine inventory and quarantine any affected units, return any affected product that they may have on hand for credit or replacement, notify customers or personnel if the affected product was further distributed or transferred, and complete and return the response form.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2024-05-07
Posted by FDA: 2024-09-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209514. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.