Recall Z-1628-2013
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
-90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502 -Acromioplasty Electrode (Grey) 6.5" x 165mm. Ref. C5012A Lot 122288 -CAPSure 30 ArthroWand, CW, 30 Degree Shaft Angle, (Grey) 3.0mm. Ref. AC 1830-01 Lot 122494 -Coblator II Evac 70 Xtra Plasma Wand, w/Integrated Saline Line & Integrated Cable. Ref. EIC 5872-01 Lot 122295, 122308, 122626, 122325, -Coblator II, ENT ReFlex Ultra 45 w/Integrated Cable, (Blue). Ref. EIC 4845-01 Lot 122651, 122419, 122671, 122633 Electrosurgical cutting and coagulation device and accessories. -CoVac 50, Suction ArthroWand, w/Integrated Cable, (White/Grey). Ref. ASC 2530-01 Lot 122483, 122745 -CoVac 70, ICW ArthroWand 70 angle 3.0mm. Ref. ASC 3730-01 Lot 122483, -Eliminator, Right Angle ArthroWand (Beige). Ref. A 1345-01 Lot 122446 -Eliminator, Right Angle ArthroWand, 90 Degree w/Integrated Cable, (Grey) 4.5mm. Ref. AC 1345-01 Lot 122494, 122446 -ENT Coblator II PROcise XP Wand, w/Integrated Cable, Suction & Saline, (Blue). Ref. EIC 8872-01 Lot 122651, 122762 -Ligament Chisel Probe,Curved w/Integrated Cable, (Grey/Green). Ref. 7209647 Lot 122512 -LightWave Suction Ablator, 90 Degree, Hand Control, Multi-Angle, (Blue/White) 4.5mm x 142mm. Ref. IA-2000-S Lot 122512 -Lo-Pro 90 Degree ArthroWand, w/Integrated Cable, (Grey) 3.6mm. Ref. AC1336-01 Lot 122654, 122325 -Meniscectomy Electrode, Standard Design (Grey) 165mm. Ref. C5010A Lot 122765 -MeniVac ArthroWand w/Suction, w/Integrated Cable, (Grey) 3.0mm. Ref. ASC 5500-01 Lot 122630, 122494 -Microblastor 30 Wand, 30 Degree, w/Integrated Cable, (Grey) 0.9mm Tip. Ref. AC 40500-01 Lot 122293 -Right Angle ArthroWand, 90 Degree, w/Integrated Cable, (Grey) 3.5mm. Ref. AC 1340-01 Lot 123044, 122673 -Saber 30 ArthroWand, 30 Degree, w/Integrated Cable, (Grey) 3.0mm. Ref. AC 4330-01 Lot 122630, 122494, 123044, 122283, 122765 -SAPHYRE II Bipolar Ablation Probe, w/suction, High Profile 50 Degree, (Pewter). Ref. 7210112 Lot 122734 -SERFAS ENERGY Hook Probe 3.5mm. Ref. 279-350-501 Lot 123266 -Small Joint ArthroWand, Short Bevel 35, w/Integrated Cable, Suction (Grey/White) 2.3mm. Ref. AC 2823-01 Lot 122494, 122663 -StarVac ArthroWand, Short Bevel 35, w/Integrated Cable, Suction (Grey)5.5mm. Ref. ASC 4251-01 Lot 122630, 122593, 122483, 123044, 122283, 122595 -Super MultiVac 50, 50 Degree, w/Suction and Integrated Cable, (Grey/Black) 3.0mm. Ref. ASC 4830-01 Lot 122029, 123044, 122663 -Super TurboVac 90, 90 Degree Suction ArthroWand, (White/Grey) 3.5mm. Ref. ASC 4250-01 Lot 122029,122654, 122651, 122427, 122630, 122494, 122626, 122745, 122293, 122663, 122325, 122765 -TAC-C II Probe, w/Integrated Cable, (Blue/Grey). Ref. 7209628 Lot 122486 -TriStar 50 Suction ArthroWand, 50 Degree w/Integrated Cable, (White/Grey). Ref. ASC 4630-01 Lot 122283 -Turbinate, Tissue Coagulating Electrode, (White). Ref. 1120-4110-01 Lot 122486 -VAPR Hook Electrode W/Integrated Handpiece 3.5mm. Ref. 227305 Lot 122288, 122466 -VAPR LD, Suction Electrode, Large Diameter (Blue) 4.0mm. Ref. 225360 Lot 122512 -VAPR Premiere50-, w/Integrated Cable, Suction, (Black/White) 3.0mm. Ref. 227504 Lot 122029, 122455 -VAPR Premiere90 w/Suction tion, Integrated Cable, (Black/White) 3.3mm. Ref. 227204 Lot 122029, 122446, 122466, 122306, 122435, 122293, -VAPR S90 Suction Electrode, w/Integrated Cable, (Black/White). Ref. 225370 Lot 122577, 122455, 122593, 122288, 122466, 122589, 122356, 122639, 122325, 122318 -VAPR Side Effect Electrode (Blue) 3.5mm. Ref. 225301 Lot 122512 -VAPR Side Effect Electrode, w/Integrated Handpiece 3.5mm. Ref. 227301 Lot 122288, 122356, -VAPR Wedge Electrode (Short,) w/Integrated Cable (Black/White) 2.3mm x 85 mm. Ref. 227213 Lot 122409 -VAPR Wedge Electrode, w/Integrated Cable (Black/White) 2.3mm. Ref. 227203 Lot 122486, 122639 -VAPR Angled, Side Effect Electrode (Blue) 3.5mm. Ref. 225302 Lot 122512 -Vulcan Sa
Codes / lots: 122029, 122295, 122486, 122577, 122734, 122654, 123266, 122651, 122427, 122630, 122494, 122595, 122419, 122446, 122308, 122671, 122455, 122593, 122626, 122483, 123044, 122283, 122466, 122673, 122745, 122589, 122306, 122356, 122435, 122502, 122639, 122293, 122663, 122325, 122512, 122765, 122765, 122762, 122409, 122318.
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-1628-2013
- Initiated
- May 3, 2013
- Posted by FDA
- July 1, 2013
- Terminated
- July 11, 2013
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 447 units
- 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-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-1643-2013 Class II | - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm…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 |