Recall Z-1342-2015
Microtek Medical Inc · initiated March 10, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm x 487.88 cm), REF 24244, QTY 3/CS, NON STERILE NO LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.
Codes / lots: Lot Numbers: C11020, C11129, C11238, C11276, C12013, C12044, C12079, C12094, C12108, C12124, C12212, C12236, C12243, C12254, C12271, C12334, C13031, C13070, C13080, C13162, C13168, C13189, C13205, C13254, C13294, C13345, C14020, C14055, C14072, C14120
Reason for recall
This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
FDA-determined cause: Error in labeling
Action taken
The firm, Ecolab - Microtek Medical, sent an "Urgent: Recall - Mislabeled Product Immediate Action Required" letter dated March 2015 to its US customers on 03/10/2015 via letter and email. The letter describes product, problem and actions to be taken. The customers were instructed to immediately examine your inventory and promptly quarantine the lot(s) listed; complete and return the enclosed Recall Response Form via fax to Quality Assurance Manager, Ecolab-Microtek Medical at (662) 244-3011 or email to: recall@ecolab.com RE: Recall - Mislabeled Product ASAP, and if you have further distributed the products subject to this recall, please notify your customers at once. Upon receipt of the completed response forms, Ecolab-Microtek Medical will issue a return material authorization (RMA) and ask that you return any unopened product listed above to Ecolab-Microtek Medical at the address listed in the attached form. If you have any questions in regard to this recall, please contact Customer Service by phone at 1-800-824-3027 or email; customerservice@microtekmed.com.
Details
- Recall number
- Z-1342-2015
- Initiated
- March 10, 2015
- Posted by FDA
- March 27, 2015
- Terminated
- January 21, 2017
- Product code
- FYD – Apparatus, Exhaust, Surgical
- Quantity
- 303 units
- Distribution
- US (nationwide) Distribution.
- Recalling firm
- Microtek Medical Inc, Columbus, MS
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1337-2015 Class II | FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1338-2015 Class II | FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1339-2015 Class II | FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1340-2015 Class II | FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO LATEX…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1341-2015 Class II | LAPAROSCOPIC TUBING SET, 3/16" X 10' (48cm x 304.8cm) WITH MALE LUER LOCK - STERILE, REF…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1343-2015 Class II | TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO Intended use:…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1344-2015 Class II | VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERILE Intended…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1345-2015 Class II | VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, REF 24010…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1346-2015 Class II | TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE, NO LATEX…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1347-2015 Class II | (S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Sterile, REF…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1348-2015 Class II | LASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QTY 10 EA…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1349-2015 Class II | INTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO Intended use: The…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |