EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
FDA device recall Z-1938-2015 · posted 2015-06-29 · Terminated
Recall details
- Recalling firm
- Atrium Medical Corporation
- Reason for recall
- Chest drains have a missing o-ring
- Action taken
- Atrium Medical issued recall letter dated 5/7/15 to inform customers of the steps to take should they encounter affected product. If the O-ring is not present on the patient tubing: a. Do not use the chest drain. b. Replace the entire chest drain including the patient tubing. Open up another chest drain package and repeat steps 1 to 3. c. Return any units with missing O-rings to Atrium. If the O-ring is present then reconnect in-line connector and proceed with set up as normal. Complete and return Field Action Reply Form to the following e-mail address: connector@atriummed.com or you may fax it to 1-603-386-6590. If you have any questions, please contact your local Atrium/Maquet chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST).
- Root cause
- Process control
- Status
- Terminated
- Product code
- PAD
- Quantity affected
- 390 cases
- Distribution
- Nationwide Canada, Germany
- Date initiated
- 2015-05-07
- Date posted
- 2015-06-29
- Date terminated
- 2016-04-26
- Location
- Hudson, NH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXPRESS CHEST DRAIN (K081718) | Atrium Medical Corp. | 2008-07-25 |
| OCEAN CHEST DRAIN (K043582) | Atrium Medical Corp. | 2005-01-21 |
| EXPRESS AND OASIS CHEST DRAIN (K043140) | Atrium Medical Corp. | 2004-12-08 |