International Surgical Supply, Inc.
Miami, FL
International Surgical Supply, Inc. appears in FDA device records in Miami, FL. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 22 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 22
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1278-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Needle, Ultra Veress. | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated | ||
| Z-1277-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Cutter, Linear Vascular, Item # TSB-35. | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated | ||
| Z-1276-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Thoracic Trocar Sleeve, rounded tip, Item # TT012. | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated | ||
| Z-1275-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Needle, 120 mm, Pneumopcritoneum, item # PN120. | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated | ||
| Z-1274-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Hook, Dissecting Harmonic Scalpel Blade 10 cm., item # DH105. | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated | ||
| Z-1273-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Clip Applier, Multiple MCA, 20 clips 9 3/8 inch, item # MCS 20. | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated | ||
| Z-1272-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Cutter, ETS Endoscopic Linear, 35 mm, item # TSB 35. | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated | ||
| Z-1271-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Shears, Coagulating, item CS150. | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated | ||
| Z-1270-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Scissors, curved with unipola 5 mm. | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated | ||
| Z-1269-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Trocar, Tristar, blunt tip, item 512B. | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated | ||
| Z-1268-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Trocar, Dilating Tip, 10/12 mm, 100 length w/stability sleeve, Item # 512SD. | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated | ||
| Z-1267-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Stapler, Articulating, Linear, item # AX55 | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated | ||
| Z-1266-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Stapler, Posered LDS Single Use, item # 092001 | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated | ||
| Z-1265-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: TX Stapler, Reloadable, Linear 30 mm and 60 mm, item numbers TX30 and TX60 | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated | ||
| Z-1264-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Stapler EMS Endo Hernia , item # 8034. | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated | ||
| Z-1263-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Blade, 5 mm Curved Harmonic, item HC325. | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated | ||
| Z-1262-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Laparosonic coagulating curved Pistal grip 5 mm, curved, Item Number LCSC5 | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated | ||
| Z-1261-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Cutter, Linear 55mm and 75mm, item numbers TCT75 and TLC55. | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated | ||
| Z-1260-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Linear Cutter, Thick tissue 75 mm, item code TCT75. | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated | ||
| Z-1259-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Reloads for Devices EZ45, ET45, NK45 Thick Tissue, item ZR45G | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated | ||
| Z-1258-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: 5mm Curved Shears, Scissors Grip Handle 14cm Item Code CS14C. | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated | ||
| Z-1257-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a ''Stapler, reload, TR35W, TR776, TCR 75, TCR 55, TRT75, | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain