FDAClass IIAugust 21, 2013

Case Lid and Base recall

Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A…

Why was Case Lid and Base recalled?

Non-toxic inks, used on the silk screen graphics of the case bases and lids, and caddy lids, were found to be either delaminating or running off from the substrate after repeated washing and sterilization cycles.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Inspan Lid: Part Number: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A, Lot Numbers: 7197.024, 011649, 011498; Invue Lid: SI70095A, Lot Number: 6250.009-R; S-Lift Lid: SI50070A, Lot Number: 7201.008; S-Lift Base: SI50067A; Lot Numbers: 7183.007R, 7201.007; Arena-C Lid: 11-72013D, 11-72014D, Lot Numbers: 011969-001, 011969-002; Generics Lid: 12-99005A, Lot Number: 8372.001.

Product
Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A…
Recalling firm
SpineFrontier, Inc.
Quantity
258 units (30 in distribution at the time of the recall)
Distribution
Worldwide Distribution-USA including the states of FL, OH, MA, and TX, and the countries of Mexico, and Dominican Republic.
Recall date
August 21, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls