Z-0242-2015Class I
Tracheotomy Care Kit, Catalog number 900-110. Used by medical staff to perform patient care procedures such...
Customed, Inc / initiated 2014-10-08 / Terminated / root cause: packaging
Customed, Inc began a recall of Tracheotomy Care Kit, Catalog number 900-110. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds... 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-0242-2015
- Classification
- Class I
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Customed, Inc
- Product
- Tracheotomy Care Kit, Catalog number 900-110. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Product code
- NXA Tracheotomy Care Kit
- 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
- 78600
- Distribution
- US Distribution to Florida, New York and Puerto Rico..
- Product codes and lots
- Lot numbers: 111102823 111112980 111123314 111123440 112020308 112020361 112030826 112041369 112041434 112051646 112062317 112083160 112093741 112104363 112124894 113015487 113035832 113046996 113047144 113057604 113057810 113078456 113078674 113089014 113109706 131110154 131110288 131210677 140111108 140211531 140312046 140412578 140513065 140613570 140714155 140714430 140814942
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.