Z-0307-2015Class I
Open Heart Tray, Catalog number 900-170. Used by medical staff to perform patient care procedures such as...
Customed, Inc / initiated 2014-10-08 / Terminated / root cause: packaging
Customed, Inc began a recall of Open Heart Tray, Catalog number 900-170. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc on . FDA classified it as Class I and gives the reason as "Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions...". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-0307-2015
- Classification
- Class I
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Customed, Inc
- Product
- Open Heart Tray, Catalog number 900-170. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Product code
- OFA Cardiovascular Surgical Instruments Tray
- Reason for recall
- Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
- Root cause tag
- packaging
- FDA root cause
- Packaging
- Action
- Customed initiated a recall on October 8th, 2014 of sterile convenience surgical Packs-trays, bags (known as Convenience Packs) and new lots of products added to the initial June 3, 2014 recall of 233 sterile surgical packs. The products are being recalled because of significant compromised sterility, not limited to potentially damaged packaging. Customers were instructed to quarantine and cease use of the affected product identified. Customers are to return the response form included with the letter, to the contact information provided. Upon receipt, the firm will contact customers with further instructions to obtain credit, replacement product, and for return of the recalled product or any other disposition action. If customers have any questions, they should contact the Customed Recall Coordinator at 407-850-5558 extensions 8001 or 8005, or via e-mail: [email protected].
- Quantity in commerce
- 160
- Distribution
- US Distribution to Florida, New York and Puerto Rico..
- Product codes and lots
- Lot numbers 140513106 140513245 140613821 140714336 140814672 140814948
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0237-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0238-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0239-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0240-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0241-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0242-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0243-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0244-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0245-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0246-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0247-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0248-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0249-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0250-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0251-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0252-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0253-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0254-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0255-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0256-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0257-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0258-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0259-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0260-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0261-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0262-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0263-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0264-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0265-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0266-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0267-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0268-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0269-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0270-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0271-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0272-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0273-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0274-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0275-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0276-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0277-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0278-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0279-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0280-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0281-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0282-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0283-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0284-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0285-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0286-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0287-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0288-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0289-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0290-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0291-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0292-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0293-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0294-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0295-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0296-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0297-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0298-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0299-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0300-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0301-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0302-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0303-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0304-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0305-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0306-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0307-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0308-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0309-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0310-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0311-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0312-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0313-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0314-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0315-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0316-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0317-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0318-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0319-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0320-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0321-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0322-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0323-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0324-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0325-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0326-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0327-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0328-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0329-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0330-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0331-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0332-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0333-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0334-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0335-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0336-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0337-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0338-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0339-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0340-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0341-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0342-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0343-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0344-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0345-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0346-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0347-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0348-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0349-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0350-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0351-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0352-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0353-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0354-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0355-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0356-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0357-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0358-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0359-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0360-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0361-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0362-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0363-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0364-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0365-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0366-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0367-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0368-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0369-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0370-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0371-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0372-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0373-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0374-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0375-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0376-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0377-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0378-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0379-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0380-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0381-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0382-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0383-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0384-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0385-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0386-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0387-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0388-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0389-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0390-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0391-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0392-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0393-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0394-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0395-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0396-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0397-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0398-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0399-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0400-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0401-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0402-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0403-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0404-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0405-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0406-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0407-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0408-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0409-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0410-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0411-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0412-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0413-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0414-2015 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-0415-2015 | Class I | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.