MORPH ACCESSPRO Steerable Introducer recall
MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic…
Why was MORPH ACCESSPRO Steerable Introducer recalled?
Tyvek packaging may be worn, causing loss of package integrity.
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?
Catalog number MAP690; Lot numbers 01162 and 01186.
- Product
- MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic…
- Recalling firm
- Biocardia, Inc.
- Quantity
- 11 units
- Distribution
- US Distribution including the states of FL, MA, WY. OH, MI and KS.
- Recall date
- February 26, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)