Cardiovascular Procedure Kit catalog # 76645 & 73806
This recall has been terminated (originally issued February 3, 2022).
- Recall Initiated
- February 3, 2022
- Terminated
- February 20, 2024
- Recall Number
- Z-0949-2022
- Quantity
- 64
- Firm Location
- Ashland, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.
Distribution
US Nationwide distribution in the states of CA and IN.
Lot / Code Info
[Lot #Z15957677, case label GTIN: (01)00699753507685, product identifier: (17)230228(10)Z15957677] and [Lot #Z16958398, case label GTIN: (01)00699753477728, product identifier: (17)230228(10)Z16958398]
Root Cause
Under Investigation by firm
Action Taken
A customer notification letter was issued on 02/23/2022 by 2-day FedEx mailing advising customers to remove the affected product from use and return to Terumo CVS using the instructions provided.
More recalls by Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard Leukocyte Reduction Arterial B...
Dec 18, 2017
Tubing Pack Convenience Kit, Product Code 65217
Product Usage:
Intended for use only in the extraco...
May 12, 2017
Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing...
Jul 25, 2016