Reported Feb 26, 2014 · Terminated
Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK.…
Merit Medical Systems, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 12701 N Kingston Ave · Chester, VA · 23836-2700
Is this the product you have?
- Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Custom Procedural Tray or kit is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Custom procedural trays or kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
- Lot codes and dates
307 of 307 products
Products covered by this recall # Product as published 1 Lot # T491273 , Exp. 31-Dec-2014, SPPT-5F-10/D 2 Lot # T512967, Exp.31-Dec-2014, K12T-04453 3 Lot # T472220, Exp. 31-Dec-2014, K12T-04454 4 Lot # T487452, Exp. 31-Dec-2014, K12T-04455B 5 Lot # T479169, Exp. 31-Dec-2014, K12T-04455B 6 Lot # T502497, Exp. 31-Jul-2014, K12T04455B 7 Lot #T479169, Exp. 31-Dec-2014, K12T-03650C 8 Lot #T483624, Exp. 31-Oct-2014, K12T-04082B 9 Lot #T479165, Exp. 31-Oct-2014, K12T-06488 10 Lot #T475046, Exp. 30-Nov-2014, SPPT-5F-10/D 11 Lot #T51296, Exp. 31-Dec-2014, SPPT-5F-10/D 12 Lot #T491273, Exp. 31-Dec-2014, TAPS-5F-10LT 13 Lot #T486378, 31-Dec-2014, TAPS-5F-10T 14 Lot#T486379, 31-Dec-2014, SPPT-5F-10L/B 15 Lot #T486376, 31-Dec-2014, K12T-06292 16 Lot #T502623, 31-Dec-2014, SPPT-5F-7L/B 17 Lot #T486377, 31-Dec-2014, SPPT-5F-7L/B 18 Lot #489467, 31-Dec-2014, K12T-03502A 19 Lot #T506171, 31-Dec-2014, K12T-04021D 20 Lot #T450842, 31-Dec-2014, K12T-04021D - Amount recalled
- 20, 872 trays
Where it was sold
Why it was recalled
Stop using this product now
Custom Procedural Trays/Kits contain 1% Lidocaine HCl injection which were recalled because one confirmed customer report where visible particulate were found in the primary product container in the form of dark red/black particles. The particular matter may dislodged through the tissue and could possibly cause a pneumothorax or hemothorax.
Using this product could cause serious injury, illness or death — stop using it now.
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