Z-1475-2016Class II

Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE Used by...

Name: Z-1475-2016 Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE Used by...
Creator: Customed, Inc
Published: 2016-01-07
License: https://open.fda.gov/license/

Customed, Inc / initiated 2016-01-07 / Terminated / root cause: packaging

FDA source

Customed, Inc began a recall of Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE Used by medical staff to perform surgical procedures and patient... on 2016-01-07. FDA classified it as Class II and gives the reason as "Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1475-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-07
Posted: 2016-04-14
Terminated: 2017-05-03
Recalling firm: Customed, Inc
Product: Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Product code: FYA Gown, Surgical
Reason for recall: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Root cause tag: packaging
FDA root cause: Packaging
Action: Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.
Quantity in commerce: 1148
Distribution: Distributed only in Puerto Rico.
Product codes and lots: LOTS: SL15174 (150518822) 31-MAY-16 SL15176 (150317997) 31-MAR-16 SV15168 (150418241) 30-APR-16 SV15168 (150117022) 31-MAR-16 SL15180 (150418241) 30-APR-16 SL15209 (150720052) 31-JUL-16 SL15210 (150720052) 31-JUL-16 SL15218 (150720052) 31-JUL-16 SL15219 (150720052) 31-JUL-16 SL15222 (150720052) 31-JUL-16 SL15246 (150820337) 31-AUG-16 SL15251 (150820337) 31-AUG-16 SL15252 (150820337) 31-AUG-16

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1475-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1397-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1398-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1399-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1400-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1401-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1402-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1403-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1404-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1405-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1406-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1407-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1408-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1409-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1410-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1411-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1412-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1413-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1414-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1415-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1416-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1417-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1418-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1419-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1420-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1421-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1422-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1423-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1424-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1425-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1426-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1427-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1428-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1429-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1430-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1431-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1432-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1433-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1434-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1435-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1436-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1437-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1438-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1439-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1440-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1441-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1442-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1443-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1444-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1445-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1446-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1447-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1448-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1449-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1450-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1451-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1452-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1453-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1454-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1455-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1456-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1457-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1458-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1459-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1460-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1461-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1462-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1463-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1464-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1465-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1466-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1467-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1468-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1469-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1470-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1471-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1472-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1473-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1474-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1475-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1476-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1477-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1478-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1479-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1480-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1481-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1482-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1483-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1484-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1485-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1486-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1487-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1488-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1489-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1490-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1491-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1492-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1493-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1494-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1495-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14
Z-1496-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14

Product code FYA

K971920Class IIGown Poly Reinforced Large(product No.900-522)/(Reorder No. 0522)Customed, Inc. / cleared 1997-12-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)