Recall Z-1643-2013
Surgical Instrument Service And Savings, Inc. · initiated May 3, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
- ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref. 511NA Lot 123215, 122647 - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Orange) 5.0mm Ref. 35LNA Lot 123215, 122647 - ENDOPATH Resposable Trocar w/Dilating Tip Obturator & Housing, 100mm, (Orange) 5mm Ref. 35LDA Lot 122647 - ENDOPATH Resposable Trocar, Dilating Tip w/Housing, 100mm, (Purple) 10/12mm Ref. 512DA Lot 123215 - ENDOPATH Sleeve Housing (Orange) 5mm Ref. 355HR Lot 123215, 122647 Endoscope and accessories - ENDOPATH Trocar, Disposable Sleeve Housing, (Green) 10/11mm Ref. 511HR Lot 122647 - ENDOPATH Blunt Tip Obturator & Housing, w/Olive Plug, 100mm, (Purple) 10/12mm Ref. 512BA Lot 122647 - ENDOPATH Resposable Trocar w/ Dilating Tip Obturator & Housing, 100mm, (Green) 10/11mm Ref. 511DA Lot 122454, 122647 - ENDOPATH, Bladeless Trocar with Stability Sleeve, Non-handled 10/12mm Ref. 512NT Lot 123254 - ENDOPATH Xcel Bladeless Trocar, Handled, w/Stability Sleeve, (Teal) 11mm x 100mm Ref. 811LTH Lot 122300 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve 12mm x 150mm Ref. B12XT Lot 122300 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve 5.0mm x 150mm Ref. B5XT Lot 122429 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, (Teal) 11mm x 100mm Ref. B11LT Lot 122454, 123254, 122429 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, 100mm Length 5.0mm Ref. B5LT Lot 122347, 122454, 122592, 122490, 123254, 122429, 122300 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, 75mm Length, (Teal) 5.0mm Ref. B5ST Lot 123254 - ENDOPATH Xcel Blunt Tip Trocar, w/Smooth Sleeve & Adjustable Plug, (Purple) 12mm x 100mm Ref. H12LP Lot 122338, 122372, 123254, 123215 - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 11mm x 100mm Ref. D11LT Lot 122454 - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 12mm x 100mm Ref. D12LT Lot 122454 - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 5.0mm x 100mm Ref. D5LT Lot 122338, 122454, 122490, 122429 - ENDOPATH Xcel Integrated Stability Trocar Sleeve 11mm x 100mm Ref. CB11LT Lot 122429 - ENDOPATH Xcel Integrated Stability Trocar Sleeve 12mm x 100mm Ref. CB12LT Lot 122490 - ENDOPATH Xcel Integrated Stability Trocar Sleeve 5.0mm x 100mm Ref. CB5LT Lot 122490, 122429, 122300 - Kii Optical Access System Threaded (Blue) 5mm x 100mm Ref. C0Q04 Lot 122609
Codes / lots: 122338, 122347, 122454, 122592, 123372, 122490, 122490, 123254, 122609, 122429, 123215, 122647, 122300.
Reason for recall
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
FDA-determined cause: Packaging process control
Action taken
MEDISISS sent a Correction Immediate Action Request letter dated May 2, 2013, to all affected customes. The letter identified the product, the problem, and the action to be taken by the customer. The letter directed the customer to inspect the products prior to use for seal integrity as specified on the product labeling: "Sterile unless package has been damaged or opened. Do not use if package is damaged." This will be followed up by a visit from the customer's sales representatives who are tasked with inspecting all the lots that may be remaining in the customer's inventory. The sales representative is directed to complete a "Verification of Seal Inspection" form and return it to MEDISISS Customer Relations. Devices with unacceptable seals are to be returned to MEDISISS. The sales representative is responsible for obtaining a shipping label from customer service to enable the devices to be returned to the recalling firm via Fed Ex. Customers with questions were instructed to call 866-866-7477.
Details
- Recall number
- Z-1643-2013
- Initiated
- May 3, 2013
- Posted by FDA
- July 1, 2013
- Terminated
- July 11, 2013
- Product code
- NLM – Laparoscope, General & Plastic Surgery, Reprocessed
- Quantity
- 259
- Distribution
- Nationwide Distribution.
- Recalling firm
- Surgical Instrument Service And Savings, Inc., Redmond, OR
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1623-2013 Class II | -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 -…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | 05/03/2013Terminated |
| Z-1624-2013 Class II | - ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) 4.0 x 20.0mm. REF…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | 05/03/2013Terminated |
| Z-1625-2013 Class II | -ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | 05/03/2013Terminated |
| Z-1626-2013 Class II | GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2.…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | 05/03/2013Terminated |
| Z-1627-2013 Class II | -Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N Lot 123263…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | 05/03/2013Terminated |
| Z-1628-2013 Class II | -90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue)…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | 05/03/2013Terminated |
| Z-1629-2013 Class II | - Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 122455…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | 05/03/2013Terminated |
| Z-1630-2013 Class II | - Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447 -…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | 05/03/2013Terminated |
| Z-1631-2013 Class II | - Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | 05/03/2013Terminated |
| Z-1632-2013 Class II | Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | 05/03/2013Terminated |
| Z-1633-2013 Class II | - Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster Burr (Brick…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | 05/03/2013Terminated |
| Z-1634-2013 Class II | Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347 Manual surgical…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | 05/03/2013Terminated |
| Z-1635-2013 Class II | - Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Drill Bit…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | 05/03/2013Terminated |
| Z-1636-2013 Class II | - IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721 Lot 122511 - IDEAL 60 Suture…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | 05/03/2013Terminated |
| Z-1637-2013 Class II | TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | 05/03/2013Terminated |
| Z-1638-2013 Class II | - Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | 05/03/2013Terminated |
| Z-1639-2013 Class II | - Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429 -…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | 05/03/2013Terminated |
| Z-1640-2013 Class II | - ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 -…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | 05/03/2013Terminated |
| Z-1641-2013 Class II | - CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref.…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | 05/03/2013Terminated |
| Z-1642-2013 Class II | - Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref.…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | 05/03/2013Terminated |
| Z-1644-2013 Class II | Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White)…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | 05/03/2013Terminated |