Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures.
Reported: September 30, 2015 Initiated: August 19, 2015 #Z-2799-2015
Product Description
Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures.
Reason for Recall
Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
Details
- Recalling Firm
- Resource Optimization & Innovation Llc
- Units Affected
- 67 kits
- Distribution
- Distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC.
- Location
- Springfield, MO
Frequently Asked Questions
What product was recalled? ▼
Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures.. Recalled by Resource Optimization & Innovation Llc. Units affected: 67 kits.
Why was this product recalled? ▼
Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 30, 2015. Severity: Moderate. Recall number: Z-2799-2015.
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