Z-1050-2021Class II
K-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 -
AOMORI OLYMPUS CO., Ltd. Kuroishi Site / initiated 2021-01-04 / Terminated / root cause: packaging
Aomori Olympus Co., Ltd. began a recall of K-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs on . FDA classified it as Class II and gives the reason as "Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-1050-2021
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- AOMORI OLYMPUS CO., Ltd. Kuroishi Site
- Product
- K-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
- Product code
- EOQ Bronchoscope (Flexible Or Rigid)
- Reason for recall
- Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Root cause tag
- packaging
- FDA root cause
- Under Investigation by firm
- Action
- On January 4, 2021, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed that the identified list of Endo-therapy devices may have a defective seal which may compromise the sterility of the product. Customers were asked to take the following actions: 1. Immediately assess any product you have in stock to identify endotherapy products with affected lot numbers listed in the recall letter. Cease use of product and quarantine any affected product. 2. Call your Olympus customer service representative at 1-888-524-7266 to obtain a Returned Goods Authorization so that you may return the product with no charge to you. Olympus will issue a credit or replacement to your facility for any returned product. 3. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-0391 and provide your contact information as indicated in the portal. 4. If you have distributed these devices outside your facility, please notify your customers of this corrective action immediately. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
- Quantity in commerce
- 7,400,000 (globally); 260,395 (US)
- Distribution
- US Nationwide distribution.
- Product codes and lots
- 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0961-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0962-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0963-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0964-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0965-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0966-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0967-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0968-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0969-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0970-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0971-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0972-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0973-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0974-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0975-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0976-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0977-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0978-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0979-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0980-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0981-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0982-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0983-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0984-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0985-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0986-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0987-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0988-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0989-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0990-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0991-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0992-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0993-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0994-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0995-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0996-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0997-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0998-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0999-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1000-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1001-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1002-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1003-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1004-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1005-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1006-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1007-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1008-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1009-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1010-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1011-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1012-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1013-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1014-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1015-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1016-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1017-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1018-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1019-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1020-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1021-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1022-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1023-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1024-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1025-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1026-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1027-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1028-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1029-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1030-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1031-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1032-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1033-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1034-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1035-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1036-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1037-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1038-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1039-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1040-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1041-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1042-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1043-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1044-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1045-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1046-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1047-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1048-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1049-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1050-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1051-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1052-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1053-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1054-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1055-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1056-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1057-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1058-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1059-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1060-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1061-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1062-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1063-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1064-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1065-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1066-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1067-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1068-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1069-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1070-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1071-2021 | Class II | 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.